Customizable Component Insole System

ABSTRACT

This invention provides for individualized adjustment to a user&#39;s specific needs through the use of multiple variable size, thickness and rigidity components that can be placed or integrated into an insole. The current invention is an insole that incorporates, but is not limited to: (1) a base layer with various depressions, (2) a metatarsal dome, (3) a first metatarsal head pad, (2) a forefoot wedge to create a pronation moment around the midfoot joint, (3) a heel cushion, (4) a heel lift to raise the heel area of the foot, (5) a rearfoot wedge to increase the supination moments around the subtalar joint, and (6) an arch support of a specific stiffness or with varying stiffness.

RELATED APPLICATION DATA

This application is related to Provisional Patent Application Ser. No.61/929,944 filed on Jan. 21, 2014, and priority is claimed for thisearlier filing under 35 U.S.C. §119(e). The Provisional PatentApplication is also incorporated by reference into this patentapplication.

TECHNICAL FIELD

The present invention relates to a shoe insole with customizablecushioning and support to the foot of a wearer.

BACKGROUND OF THE INVENTION

The human foot is a very complex biological mechanism. The many bones,muscles, ligaments, and tendons of the foot, function to absorb anddissipate the forces of impact. The load on the foot at heel strike istypically about one and a half times a person's body weight when aperson walks. When running or carrying extra weight, such as a backpack,loads on the foot can exceed three times the body weight.

The many bones, muscles, ligaments, and tendons of the foot function toabsorb and dissipate the forces of impact, carry the weight of the bodyand other loads, and provide forces for propulsion. Properly designedshoe insoles can assist the foot in performing these functions andprotect the foot from injury.

Insoles may be custom made by using a molded cast of the end user's footor may be made of a thermoplastic material that is specifically moldedto the contours of the end user's foot in a plasticized cast of theuser's foot. Like most custom made items, custom insoles tend to beexpensive because of the low volume and extensive time needed to makeand fit them properly. As such, it is not practical to make such custommade insoles for the general public. What is needed is an insole thatcan be modified for individualized adjustment and fitting, but avoidinga molded “one off” cast of the user's foot. There is a present need fora shoe insole that accomplishes the goals to: (1) provide increasedankle and foot stability, (2) cushion the heel and forefoot duringpush-offs and landings, (3) customization with multiple variablestrength and rigidity components, (4) enhanced cushioning capabilities.

The Applicant has received patents for insoles having a stability cradleand multiple pods located thereon. These patents include U.S. Pat. Nos.7,484,319, 7,665,169, 7,908,768 and 8,250,784. These patents, however,do not address the need for individualized customization of the insolebased on the components of the insole that are positioned or integratedinto the insole. Possible movement of the insole during shoe operationor provide more enhanced cushioning characteristics.

Insoles in the prior are placed inside shoes, but the various designs inthe prior art do not offer individualized customization along withsufficient cushioning and support attributes. There is a present needfor a shoe insole that accomplishes the goal of providing customizabletreatment for various ailments and prognoses, along with sufficientcushioning and support to the user's foot.

SUMMARY OF THE INVENTION

This invention provides for individualized adjustment to a user'sspecific needs through the use of multiple variable size, thickness andrigidity components that can be placed or integrated into an insole. Thecurrent invention is an insole that incorporates, but is not limited to:(1) a base layer with various depressions, (2) a metatarsal dome, (3) afirst metatarsal head pad, (2) a forefoot wedge to create a pronationmoment around the midtarsal joint, (3) a heel cushion, (4) a heel liftto raise the heel area of the foot, (5) a rearfoot wedge to increase thesupination moments around the subtalar joint, and (6) an arch support ofa specific stiffness or with varying stiffness.

The present invention uses these components individually and in variouscombinations to enhance cushioning and support for the user's footdepending on the user's individual needs. For instance, the presentinvention provides sufficient cushioning for normal use, or if needed,for more strenuous or technically challenging activities, such ascarrying a heavy backpack or traversing difficult terrain.

Moreover, present invention provides control by providing relativelystiff and rigid arch or component support so as to control the bendingand twisting of the foot by limiting foot motion. The rigid structure isgood at controlling motion, but can be adjusted to provide moreforgiving limited motion of the user during use.

The insole in the present invention, with customizable components andsupport elements, provides customizable cushioning and support to auser's foot subjected to biomechanical etiologies of the most commonmusculoskeletal pathologies of the lower limb, is herein disclosed. Thecurrent invention is an insole that incorporates various components tooptimize control and cushioning characteristics to match a user'sindividual needs, including, but is not limited to, the followingcomponents: (1) a base layer with various depressions, (2) a metatarsaldome, (3) a first metatarsal head pad, (2) a forefoot wedge to create apronation moment around the midfoot joint, (3) a heel cushion, (4) aheel lift to raise the heel area of the foot, (5) a rearfoot wedge toincrease the supination moments around the subtalar joint, and (6) anarch support of a specific stiffness or with varying stiffness.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a exploded perspective view of an illustrative embodiment ofan insole in accordance with the principles of the present invention;

FIG. 2 is a perspective view showing the bottom of the base layer of theinsole;

FIG. 3 is a top (dorsal) view of the insole;

FIG. 4 is a bottom (plantar) view of the insole;

FIG. 5 is a lateral (outer side) view of the insole;

FIG. 6 is a medial (inner side) view of the insole;

FIG. 7 is a rear (proximal) view of the insole;

FIG. 8 is a longitudinal cross sectional view of the insole of FIG. 4;

FIG. 9 is a transverse cross sectional view behind the metatarsal areaof the insole of FIG. 4;

FIG. 10 is a transverse cross sectional view along the heel area of theinsole of FIG. 4;

FIG. 11 is a view of the bones of the foot superimposed on a bottom(plantar) view of the insole;

FIG. 12 is a bottom (plantar) view illustrating the various areas of theinsole;

FIG. 13A is a bottom (plantar) view of the first metatarsal head pad;

FIG. 13B is a medial view of the first metatarsal head pad;

FIG. 14A is a perspective view of a first embodiment of the archsupport;

FIG. 14B is a bottom (plantar) view of a first embodiment of the archsupport;

FIG. 14C is a rear (proximal) view of a first embodiment of the archsupport;

FIG. 14D is a sectional view of a first embodiment of the arch support;

FIG. 15A is a perspective view of a second embodiment of the archsupport;

FIG. 15B is a bottom (plantar) view of a second embodiment of the archsupport;

FIG. 15C is a rear (proximal) view of a second embodiment of the archsupport;

FIG. 15D is a sectional view of a second embodiment of the arch support;

FIG. 16A is a perspective view of a third embodiment of the archsupport;

FIG. 16B is a bottom (plantar) view of a third embodiment of the archsupport;

FIG. 16C is a rear (proximal) view of a third embodiment of the archsupport;

FIG. 16D is a sectional view of a third embodiment of the arch support;

FIG. 17A is a perspective view of a forefoot wedge;

FIG. 17B is a bottom (plantar) view of a forefoot wedge;

FIG. 17C is a rear (proximal) view of a forefoot wedge;

FIG. 18A is a perspective view of a heel cushion;

FIG. 18B is a bottom (plantar) view of a heel cushion;

FIG. 18C is a medial view of a heel cushion;

FIG. 19A is a perspective view of a heel lift;

FIG. 19B is a bottom (plantar) view of a heel lift;

FIG. 19C is a sectional view of a heel lift;

FIG. 20A is a perspective view of a rearfoot wedge;

FIG. 20B is a bottom (plantar) view of a rearfoot wedge;

FIG. 20C is a sectional view of a rearfoot wedge.

DETAILED DESCRIPTION

All insoles with a heel cup and medial longitudinal arch support willprovide a small degree (research suggests 2-3 degrees) of pronationcontrol. Pronation control is the degree of heel eversion and loweringof the medial longitudinal arch.

A number of respected researchers have proposed that kinematic changesin foot function may not be the primary pathway through whichmusculoskeletal aches, pains, and chronic injuries improve with the useof insoles. The present insole invention disclosed herein is areplacement insole primarily designed to be adaptable to address boththe kinematic and kinetic causes of common musculoskeletal pathologiesof the foot and leg, thereby providing optimum control and cushioningcharacteristics for a user's individual needs.

The current invention is an insole that incorporates various componentsto optimize control and cushioning characteristics to match a user'sindividual needs, including, but is not limited to, the followingcomponents: (1) a base layer with various depressions, (2) a metatarsaldome, (3) a first metatarsal head pad, (2) a forefoot wedge to create apronation moment around the midfoot joint, (3) a heel cushion, (4) aheel lift to raise the heel area of the foot, (5) a rearfoot wedge toincrease the supination moments around the subtalar joint, and (6) anarch support of a specific stiffness or with varying stiffness.

In reference to FIGS. 1 to 20C, an insole constructed in accordance withthe principles of the present invention is disclosed. It should beunderstood that insoles are generally adapted to be inserted inside auser's shoe. A user's right shoe and left shoe are mirror images of oneanother as are the insoles adapted to be inserted in a right shoe and aleft shoe respectively. Only the left insole is illustrated in theFigures. It will be understood by those of skill in the art that theright insole has a mirror image construction of the left insole.

Except as noted herein, the insole of the invention is shapedessentially like the bottom interior of a shoe (and therefore adapted toreceive a user's foot which has a generally similar shape when at rest).The insole extends from a heel end (proximal) to a toe end (distal) andhas a medial border or side on the arch side of the foot, connectingsaid toe end to said heel end along the arch side of the insole and alateral border or side on the other side thereof, connecting said toeend to said heel end on the other side of the insole. The insole alsohas a forefoot area (area that correlates with the metatarsals andphalanges of the foot), an arch area (along the medial side), a heelarea (just forward of the heel end), and a midfoot area (between theheel area and forefoot area). The arch area of the insole does not layflat on the inside of the user shoe, but provides an elevation supportto the arch area of the user's foot.

As shown in the exploded view of FIG. 1, insole 101 preferably comprisesa top sheet 103 (top sheet 103 is shown facing up to show surfacedetails) and a base layer 105, said base layer 105 having a top surface105A secured to said top sheet 103 and an opposite bottom surface 105B.Preferably, said top surface 105A of said base layer 105 defines anupwardly-extending portion or metatarsal dome 138 (as shown in FIGS. 3,5, 6, 8 and 9) that lies behind the 2^(nd) through 4^(th) plantarmetatarsal area of the foot. Base layer 105 also defines a longitudinalarch support 106 that extends upwardly along the medial side of theinsole to provide extra cushion and support to the arch area of thefoot.

Base layer 105 has a raised edge that wraps around the heel and extendspartially along the sides of the foot such that the insole has a heelcup, which conforms to the natural shape of the foot. As seen in FIGS.5-8 and 10, the height of the raised edge is generally higher andthicker on the adjacent the medial border of the insole and is lower andthinner adjacent to the lateral border of the insole. The raised edge isespecially higher along the longitudinal arch support 106 compared tothe lateral border.

Base layer 105 is preferably made of foam or other material havingsuitable cushioning properties. Preferably, base layer 105 comprises anEthylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene andvinyl acetate. A preferred EVA foam has a durometer (hardness) of about55-60 Asker C. Other materials may be used for base layer 105 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the base layer 105.

In a preferred embodiment, top surface 105A of base layer 105 is coveredwith top sheet 103, which is preferably a non-woven fabric layer with alow coefficient of friction so as to minimize the possibility ofblisters. In a preferred embodiment, the fabric is treated with anantibacterial agent, which in combination with a moisture barrierreduces odor causing bacteria and fungi. A woven fabric may also beused, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 105 has anapproximate length of 264 mm, an approximate width of 86.5 mm in theforefoot area, an approximate width of 63 mm in the heel area, and anapproximate width of 76.5 through the arch and middle area. These widthsmay vary ±5 mm and still maintain the desired performance of the baselayer 105. The length may vary and may even be shortened by up to 26 mmto fit within the desired shoe. Longer or shorter lengths may also beachieved by altering all the dimensions of the base layerproportionately.

The bottom surface 105B of base layer 105 defines various depressions orareas: a forefoot wedge area 107 in the rear portion of the forefootarea, a first metatarsal head pad area 109 in the area of the firstmetatarsal, a heel cushion area 111 and rearfoot wedge/heel lift area113 in the area of the heel, and an arch support area 117 from themiddle of the insole towards the heel area near the medial side.

Base layer 105 also defines a separator wall 120 that divides the firstmetatarsal head pad area 109 from the arch support area 117. Theseparator wall 120 helps the base layer 105 define the first metatarsalhead pad area 109 and the arch support area 117 for correct placement ofthe first metatarsal head pad 110 and arch support 118 and to keep thefirst metatarsal head pad 110 and arch support 118 components frominterfering with each other. Accordingly, the first metatarsal head pad110 placed in the first metatarsal head pad area 109 is separated fromthe arch support area 117 by the separator wall 120, and as such thefirst metatarsal head pad 110 does not lie in the same depression area,or any type of recessed area, where the arch support 118 is located.

Alternatively, the bottom surface 105A of base layer 105 may only haveone or more of the defined areas: forefoot wedge area 107, firstmetatarsal head pad area 109, heel cushion area 111, rearfoot wedge/heellift area 113, and arch support area 117.

Metatarsal dome 138 preferably lies behind the 2^(nd)-4^(th)metatarsals. Metatarsal dome 138 provides a redistribution of pressureaway from the lesser metatarsals for general forefoot comfort andrelatively increases the depth of the first metatarsal head pad area 109to encourage a greater degree of first ray plantarflexion during thepropulsive phase of gait. Preferably the metatarsal dome 138 is anextension of base layer 105.

The metatarsal dome 138 preferably has a height of 2.0-3.0 mm above thetop surface 105A. The height may vary ±1 mm, but is not recommended tovary more than that as too little or too much of a metatarsal dome maynot have the desired effects.

Alternatively, metatarsal dome 138 is a conical-like component that issecured to the top surface 105A of base layer 105 in the area behind the2^(nd)-4^(th) metatarsals with the top sheet 103 secured across the topsurface 105A of base layer 105 and either over the metatarsal dome 138or allowing the metatarsal dome 138 to extend therethrough. Anotheralternative is to secure the metatarsal dome 138 to the top sheet 103 inthe area of the 2^(nd)-4^(th) metatarsals.

Preferably the metatarsal dome 138 is made of the same material as baselayer 105. Other materials may be used for metatarsal dome 138 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the metatarsal dome138.

The forefoot wedge area 107 begins just behind the 2^(nd)-5^(th)metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge 108 is shaped essentially the same as forefoot wedge area107 and is secured therein. Forefoot wedge 108 has a medial edge, alateral edge, a proximal (back) edge and a distal (front) edge. Thedistal edge lies just behind the 2^(nd)-5^(th) metatarsal heads. Themedial edge of forefoot wedge 108 extends along a line spaced laterallyfrom said medial border of said insole, essentially extending from thedistal edge to the proximal edge. The proximal edge extends from saidmedial edge transversely (or laterally) to said lateral edge, which isspaced slightly medial from said lateral border of said insole. Thelateral edge connects said proximal edge to said distal edge of saidforefoot wedge. FIG. 11 shows the placement of foot bones on the insole.An adhesive or bonding agent may be used to secure the forefoot wedge108 to the forefoot wedge area 107.

The forefoot wedge 108 has a 3° slope that tapers from the thickerlateral edge of about 4 mm thick to the thinner medial edge of about 1mm thick. The forefoot wedge 108 is used to create a pronation momentaround the midfoot joint. This moment helps stabilize the forefootagainst the rearfoot, reduce supination moments caused by a forefootvalgus deformity, offload the 1st metatarsophalangeal joint (MTPJ) byincreasing the Ground Reaction Forces (GRF) beneath the lateral aspectof the forefoot and reduce abnormal supination moments around thesubtalar joint.

The shape of the forefoot wedge 108 may vary provided that thealternative shapes maintain a distal edge approximately at or behind thelesser metatarsal heads and the medial and proximal edges do notinterfere with the first metatarsal head pad area 109 and arch supportarea 117.

Preferably, for a men's size medium insole, the forefoot wedge 108 has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge 108. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge 108 proportionately.

Preferably the forefoot wedge 108 is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forforefoot wedge 108 such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge 108.

First metatarsal head pad area 109 is an area in the bottom surface 105Bof the base layer 105 and lies under the first metatarsal head of thefoot. First metatarsal head pad 110 is shaped essentially the same asfirst metatarsal head pad area 109 and is secured to first metatarsalhead pad area 109. An adhesive or bonding agent may be used to securethe first metatarsal head pad 110 to the first metatarsal head pad area109.

In use, first metatarsal head pad 110 remains under the first metatarsalhead (i.e., the medial ball of the user's foot) and moves with it.Removing the pad reduces the GRF beneath the first metatarsal head. Thisenhances propulsion of the foot in wearers with FHL.

The first metatarsal head pad 110, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad 110 has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area 117, and a lateral edge which is curvilinear orlinear.

Preferably, for a men's size medium insole, the first metatarsal headpad 110 has a length of approximately 73.5 mm and a width ofapproximately 29.3 mm at the distal edge. The proximal end of firstmetatarsal head pad 110 comes to a point at the proximal and lateraledges. This length and width may vary ±5 mm and still maintain thedesired performance of the first metatarsal head pad 110. For differentsized insoles, the dimensions may be achieved by altering all thedimensions of the first metatarsal head pad 110 proportionately.

Preferably, said first metatarsal head pad 110 is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad 110 is about 2-2.5 mm thick or the depth of the firstmetatarsal head pad area 109. First metatarsal head pad area's 109 basicdesign is to create differential in GRF under the metatarsal heads andallow the first metatarsal head to drop below the plane of the othermetatarsals when first metatarsal head pad 110 is unattached. Othermaterials may be used for first metatarsal head pad 110 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the first metatarsalhead pad 110.

The arch support area 117 is located along the longitudinal arch support106 and has a proximal edge end nearest the heel end of the insole andextends toward said toe end of the insole to a distal edge end.Connecting said proximal edge end to said distal edge end is a medialedge and a lateral edge, with said lateral edge having a parabolic-likeshape. Arch support 118 partially wraps up the medial side of base layer105 under the medial longitudinal arch support 106. In general, itapproximately lies in the arch area of the foot or under the talus,navicular, first cuneiform, and proximal part of the first metatarsal.Arch support 118 is shaped essentially the same as arch support area 117and is secured to said arch support area 117 on bottom surface 105B ofbase layer 105. An adhesive or bonding agent may be used to secure thearch support 118 to the arch support area 117.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs 118Athat extend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs 118A areapproximately 0.5 mm thick. The width of each extending rib isapproximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support 108.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions 118C that extend inwardly from said arch support. Thisembodiment provides a flexible support in the arch area. The rib-shapeddepressions 118C are depressed into the arch support 118 about 0.5 mm.The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support 108.

A third embodiment of the arch support comprises a plurality ofextending ribs 118A that extend outwardly from said arch support, aplurality of essentially level ribs 118B having a rib outline indentedin said arch support, and a plurality of rib-shaped openings 118C thatextend inwardly from said arch support. This embodiment provides asemi-flexible or semi-rigid support in the arch area.

The arch support 118 defines, from said proximal edge end going towardsaid distal edge end, one or more extending ribs 118A, one or moreessentially level ribs 118B, and one or more rib-shaped depressions118C. Preferably, three extending ribs 118A, three of said essentiallylevel ribs 118B, and three rib-shaped depressions 118C are used. Thewidth of each rib is approximately 5 mm. The extending ribs 118A areapproximately 0.5 mm thick. The rib-shaped depressions 118C aredepressed into the arch support 118 about 0.5 mm. The essentially levelribs 118B have a rib outline approximately 0.5 mm deep

Rib-shaped depressions 118C improve flexibility at said distal edge endof arch support 118 without sacrificing longitudinal arch support at themiddle and proximal end of arch support 118.

The first three rib-shaped depressions 118C in the distal one-third ofthe arch support 118 are provided to allow the area immediately proximalto the first metatarsal head (i.e., the distal shaft of the firstmetatarsal) to remain flexible in order to encourage unrestrictedplantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support 118 (essentiallylevel ribs 118B and extending ribs 118A) are stiffened by progressivelythicker transverse bars to provide improved support to the arch and theapplication of higher magnitudes of anti-pronation GRF into the area ofthe sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support 108.

Alternatively, the rib-shaped depressions 118C may be rib-shapedopenings. The rib-shaped openings are defined to allow said base layer105 to extend therethrough. The width of each rib is approximately 5 mm.Base layer 105 is molded so that portions of its material project intothe rib-shaped openings so that such portions are approximately flushwith the outer surface of arch support 118 and mechanically lock archsupport 118 and base layer 105 together. Advantageously, the base layermaterial is also able to bulge through rib-shaped openings when baselayer 105 is compressed (e.g., while walking or running) to provideadditional cushioning.

For a men's size medium insole, the arch support 118 is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support 118.

When the foot takes up a “neutral” (i.e., neither pronated or supinated)position, the arch support is inactive or applies a gentle supination(anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies ahigher magnitude of GRF against the area beneath the sustentaculum tali(i.e., the proximal arch) increasing the supination (anti-pronation)moment to subtalar joint (i.e., the rearfoot).

The rearfoot wedge/heel lift area 113 is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area 113 isadapted to receive a supplementary pad cushion which can be a rearfootwedge 114 or a heel lift 115. The rearfoot wedge/heel lift area 113 islongitudinally angled slightly towards the lateral border so that itdoes not interfere with the arch support area 117.

The rearfoot wedge 114 has a 4° slope that tapers from the thickermedial edge of about 4 mm to the thinner lateral edge of about 1 mm. The4° rearfoot wedge 114 is used to create a supination moment (and reducethe pronation moments) around the subtalar joint.

The shape of the rearfoot wedge 114 may vary provided that thealternative shapes maintain a position within the heel area do notinterfere with the arch support area 117.

Preferably, for a men's size medium insole, the rearfoot wedge 114 has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the rearfoot wedge 114. For different sized insoles, thedimensions may be achieved by altering all the dimensions of therearfoot wedge 114 proportionately.

Preferably the rearfoot wedge 114 is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forrearfoot wedge 114 such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge 108.

The heel lift 115 approximately tapers from a thicker proximal edge ofabout 4 mm to the thinner distal edge of about 1 mm. Heel lift 115 isused to adjust the insole on a sagittal plane for the management offorefoot and ankle equinus and their associated kinetic and kinematiceffects on the musculoskeletal system of the lower limb or to balance alimb length discrepancy.

The shape of the heel lift 115 may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area 117.

Preferably, for a men's size medium insole, the heel lift 115 has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel lift 115. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift 115 proportionately.

Preferably the heel lift 115 is made of a high-density EVA material witha hardness of about 75-80 Asker C. Other materials may be used for heellift 115 such as a Polyurethane (PU), Polypropylene (PP), polyethylene(PE), or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift 115.

The heel cushion area 111 is located in the heel area of the insolewithin the boundaries of the rearfoot wedge/heel lift area 113. The heelcushion 112 may be secured in the heel cushion area 111 between the baselayer and the rearfoot wedge 114 or heel lift 115. The heel cushion 112may also be secured to the heel cushion area 111 without a rearfootwedge 114 or heel lift 115 secured thereto. The heel cushion 112provides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion 112 may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area 117.

Preferably, for a men's size medium insole, the heel cushion 112 has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion 112 and preferably smaller than therearfoot wedge 114 or heel lift 115. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heelcushion 112 proportionately.

Preferably the heel cushion 112 is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Alternatively, the heel cushionmay be a lower density material with a hardness of about 45-50 Asker C,or alternatively a medium density of 50-75 Asker C. Other materials maybe used for heel cushion 112 such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the heel cushion 112.

In a first preferred embodiment of the present invention, the variouscomponents of an insole which are secured to base layer 105 in the areasdefined by base layer 105 on bottom surface 105B are affixed to baselayer 105 using an appropriate means such as an adhesive or bondingagent.

FIG. 2 illustrates a perspective view of the bottom of the base withoutany pads, pods, or attachments. Base layer 205 has a top surface 205Aand an opposite bottom surface 205B. Base layer 205 also defines alongitudinal arch support 206 that extends upwardly along the medialside of the insole to provide extra cushion and support to the arch areaof the foot.

Base layer 205 has a raised edge that wraps around the heel and extendspartially along the sides of the foot such that the insole has a heelcup, which conforms to the natural shape of the foot. As seen in FIGS.5-8 and 10, the height of the raised edge is generally higher andthicker on the adjacent the medial border of the insole and is lower andthinner adjacent to the lateral border of the insole. The raised edge isespecially higher along the longitudinal arch area 206 compared to thelateral border.

Base layer 205 is preferably made of foam or other material havingsuitable cushioning properties. Preferably, base layer 205 comprises anEthylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene andvinyl acetate. A preferred EVA foam has a durometer (hardness) of about55-60 Asker C. Other materials may be used for base layer 205 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the base layer 205.

In a preferred embodiment, top surface of base layer 205 is covered witha top sheet, which is preferably a non-woven fabric layer with a lowcoefficient of friction so as to minimize the possibility of blisters.In a preferred embodiment, the fabric is treated with an antibacterialagent, which in combination with a moisture barrier reduces odor causingbacteria and fungi. A woven fabric may also be used, preferably with alow coefficient of friction.

Preferably, for a men's size medium insole, the base layer 205 has anapproximate length of 264 mm, an approximate width of 86.5 mm in theforefoot area, an approximate width of 63 mm in the heel area, and anapproximate width of 76.5 through the arch and middle area. These widthsmay vary ±5 mm and still maintain the desired performance of the baselayer 205. The length may vary and may even be shortened by up to 26 mmto fit within the desired shoe. Longer or shorter lengths may also beachieved by altering all the dimensions of the base layerproportionately.

The bottom surface 205B of base layer 205 defines various depressions orareas: a forefoot wedge area 207 in the rear portion of the forefootarea, a first metatarsal head pad area 209 in the area of the firstmetatarsal, a heel cushion area 211 and rearfoot wedge/heel lift area213 in the area of the heel, and an arch support area 217 from themiddle of the insole towards the heel area near the medial side.

Base layer 205 also defines a separator wall 220 that divides the firstmetatarsal head pad area 209 from the arch support area 217. Theseparator wall 220 helps the base layer 205 define the first metatarsalhead pad area 209 and the arch support area 217 for correct placement ofthe first metatarsal head pad and arch support and to keep the firstmetatarsal head pad and arch support components from interfering witheach other. Accordingly, the first metatarsal head pad placed in thefirst metatarsal head pad area 209 is separated from the arch supportarea 217 by the separator wall 220, and as such the first metatarsalhead pad does not lie in the same depression area, or any type ofrecessed area, where the arch support is located.

Alternatively, the bottom surface 205A of base layer 205 may only haveone or more of the defined areas: forefoot wedge area 207, firstmetatarsal head pad area 209, heel cushion area 211, rearfoot wedge/heellift area 213, and arch support area 217.

The forefoot wedge area 207 begins just behind the 2^(nd)-5^(th)metatarsal heads and extends proximally to the middle of the foot.

Forefoot wedge area 207 has a medial edge, a lateral edge, a proximal(back) edge and a distal (front) edge. The distal edge lies just behindthe 2^(nd)-5^(th) metatarsal heads. The medial edge of forefoot wedgearea 207 extends along a line spaced laterally from said medial borderof said insole, essentially extending from the distal edge to theproximal edge. The proximal edge extends from said medial edgetransversely (or laterally) to said lateral edge, which is spacedslightly medial from said lateral border of said insole. The lateraledge connects said proximal edge to said distal edge of said forefootwedge. FIG. 11 shows the placement of foot bones on the insole. Anadhesive or bonding agent may be used to secure the forefoot wedge tothe forefoot wedge area 207.

The shape of the forefoot wedge area 207 may vary provided that thealternative shapes maintain a distal edge approximately at or behind thelesser metatarsal heads and the medial and proximal edges do notinterfere with the first metatarsal head pad area 209 and arch supportarea 217.

Preferably, for a men's size medium insole, the forefoot wedge area 207has a length of approximately 55.9 mm and a width of approximately 51.3mm. This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge area 207. For different sized insoles,the dimensions may be achieved by altering all the dimensions of theforefoot wedge area 207 proportionately.

First metatarsal head pad area 209 is an area in the bottom surface 205Bof the base layer 205 and lies under the first metatarsal head of thefoot. An adhesive or bonding agent may be used to secure a firstmetatarsal head pad to the first metatarsal head pad area 209.

The first metatarsal head pad area 209, in shape, is a slightlyirregular polygonal shape. Preferably, said first metatarsal head padarea 209 has an essentially linear distal edge, a slightly curvilinearmedial edge which follows the curve of the medial border of the insole,a proximal edge which is curved or angled to follow the shape of themetatarsal edge of arch support area 217, and a lateral edge which iscurvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad area 209 has a length of approximately 73.5 mm and a width ofapproximately 29.3 mm at the distal edge. The proximal end of firstmetatarsal head pad area 209 comes to a point at the proximal andlateral edges. This length and width may vary ±5 mm and still maintainthe desired performance of the first metatarsal head pad area 209. Fordifferent sized insoles, the dimensions may be achieved by altering allthe dimensions of the first metatarsal head pad area 209proportionately.

The arch support area 217 is located along the longitudinal arch support206 and has a proximal edge end nearest the heel end of the insole andextends toward said toe end of the insole to a distal edge end.Connecting said proximal edge end to said distal edge end is a medialedge and a lateral edge, with said lateral edge having a parabolic-likeshape. Arch support area 217 partially wraps up the medial side of baselayer 205 under the medial longitudinal arch support 206. In general, itapproximately lies in the arch area of the foot or under the talus,navicular, first cuneiform, and proximal part of the first metatarsal.An adhesive or bonding agent may be used to secure an arch support tothe arch support area 217.

For a men's size medium insole, the arch support area 217 isapproximately 104-105 mm long. The width at the widest point, near themiddle, is about 37.5 to 38.5 mm. This length and width may vary ±5 mmand still maintain the desired performance of the arch support area 217.

When the foot takes up a “neutral” (i.e., neither pronated or supinated)position, the arch support is inactive or applies a gentle supination(anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies ahigher magnitude of GRF against the area beneath the sustentaculum tali(i.e., the proximal arch) increasing the supination (anti-pronation)moment to subtalar joint (i.e., the rearfoot).

The rearfoot wedge/heel lift area 213 is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area 213 isadapted to receive a supplementary pad cushion which can be a rearfootwedge or a heel lift. The rearfoot wedge/heel lift area 213 islongitudinally angled slightly towards the lateral border so that itdoes not interfere with the arch support area 217.

The shape of the rearfoot wedge/heel lift area 213 may vary providedthat the alternative shapes maintain a position within the heel area donot interfere with the arch support area 217.

Preferably, for a men's size medium insole, the rearfoot wedge/heel liftarea 213 has a length of approximately 71.8 mm and a width ofapproximately 46.9 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the rearfoot wedge/heel lift area213. For different sized insoles, the dimensions may be achieved byaltering all the dimensions of the rearfoot wedge/heel lift area 213proportionately.

The heel cushion area 211 is located in the heel area of the insolewithin the boundaries of the rearfoot wedge/heel lift area 213. A heelcushion may be secured in the heel cushion area 211 between the baselayer and the rearfoot wedge or heel lift. The heel cushion may also besecured to the heel cushion area 211 without a rearfoot wedge or heellift secured thereto. The heel cushion provides shock attenuation andcushioning at heel strike. Leaving the heel cushion unattached reducesthe GRF beneath the central heel area to treat certain foot pathologies,and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion area 211 may vary provided that thealternative shapes maintain a position within the heel area do notinterfere with the arch support area 217.

Preferably, for a men's size medium insole, the heel cushion area 211has a length of approximately 63.3 mm and a width of approximately 38.9mm. This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion area 211 and preferably smaller than therearfoot wedge/heel lift area 213. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heelcushion area 211 proportionately.

In a first preferred embodiment of the present invention, the variouscomponents of an insole which are secured to base layer 205 in the areasdefined by base layer 205 on bottom surface 205B are affixed to baselayer 205 using an appropriate means such as an adhesive or bondingagent.

FIG. 3 is a top view of the insole illustrating the top sheet 303 andmetatarsal dome 338. Line 9-9 indicates a transverse cross sectionbehind the metatarsal area. Line 10-10 indicates a transverse crosssection along the heel area. The insole preferably comprises a top sheet303 and a base layer, said base layer having a top surface secured tosaid top sheet 303 and an opposite bottom surface. Preferably, said topsurface of said base layer defines an upwardly-extending portion ormetatarsal dome 338 (also shown in FIGS. 5, 6, 8 and 9) that lies behindthe 2^(nd) through 4^(th) plantar metatarsal area of the foot. Baselayer also defines a longitudinal arch support 306 that extends upwardlyalong the medial side of the insole to provide extra cushion and supportto the arch area of the foot.

Metatarsal dome 338 preferably lies behind the 2^(nd)-4^(th)metatarsals. Metatarsal dome 338 provides a redistribution of pressureaway from the lesser metatarsals for general forefoot comfort andrelatively increases the depth of a first metatarsal head pad area toencourage a greater degree of first ray plantarflexion during thepropulsive phase of gait. Preferably the metatarsal dome 338 is anextension of the base layer.

The metatarsal dome 338 preferably has a height of 2.0-3.0 mm above thetop surface. The height may vary ±1 mm, but is not recommended to varymore than that as too little or too much of a metatarsal dome may nothave the desired effects.

Alternatively, metatarsal dome 338 is a conical-like component that issecured to the top surface of the base layer in the area behind the2^(nd)-4^(th) metatarsals with the top sheet 303 secured across the topsurface of the base layer and either over the metatarsal dome 338 orallowing the metatarsal dome 338 to extend therethrough. Anotheralternative is to secure the metatarsal dome 338 to the top sheet 303 inthe area of the 2^(nd)-4^(th) metatarsals.

Preferably the metatarsal dome 338 is made of the same material as thebase layer. Other materials may be used for metatarsal dome 338 such asa Polyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the metatarsal dome338.

In a preferred embodiment, top surface of base layer is covered with topsheet 303, which is preferably a non-woven fabric layer with a lowcoefficient of friction so as to minimize the possibility of blisters.In a preferred embodiment, the fabric is treated with an antibacterialagent, which in combination with a moisture barrier reduces odor causingbacteria and fungi. A woven fabric may also be used, preferably with alow coefficient of friction.

FIG. 4 illustrates the bottom view of the insole. The insole preferablycomprises a top sheet and a base layer 405, said base layer 405 having atop surface secured to said top sheet and an opposite bottom surface405B. Base layer 405 also defines a longitudinal arch support 406 thatextends upwardly along the medial side of the insole to provide extracushion and support to the arch area of the foot. Line 8-8 indicates alongitudinal cross section of the insole. Line 9-9 indicates atransverse cross section behind the metatarsal area. Line 10-10indicates a transverse cross section along the heel area.

Base layer 405 has a raised edge that wraps around the heel and extendspartially along the sides of the foot such that the insole has a heelcup, which conforms to the natural shape of the foot. As seen in FIGS.5-8 and 10, the height of the raised edge is generally higher andthicker on the adjacent the medial border of the insole and is lower andthinner adjacent to the lateral border of the insole. The raised edge isespecially higher along the longitudinal arch area 406 compared to thelateral border.

Base layer 405 is preferably made of foam or other material havingsuitable cushioning properties. Preferably, base layer 405 comprises anEthylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene andvinyl acetate. A preferred EVA foam has a durometer (hardness) of about55-60 Asker C. Other materials may be used for base layer 405 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the base layer 405.

Preferably, for a men's size medium insole, the base layer 405 has anapproximate length of 264 mm, an approximate width of 86.5 mm in theforefoot area, an approximate width of 63 mm in the heel area, and anapproximate width of 76.5 through the arch and middle area. These widthsmay vary ±5 mm and still maintain the desired performance of the baselayer 405. The length may vary and may even be shortened by up to 26 mmto fit within the desired shoe. Longer or shorter lengths may also beachieved by altering all the dimensions of the base layerproportionately.

The bottom surface 405B of base layer 405 defines various depressions orareas: a forefoot wedge area 407 in the rear portion of the forefootarea, a first metatarsal head pad area 409 in the area of the firstmetatarsal, a heel cushion area 411, rearfoot wedge/heel lift area 413in the area of the heel, and an arch support area 417 from the middle ofthe insole towards the heel area near the medial side.

Base layer 405 also defines a separator wall 420 that divides the firstmetatarsal head pad area 409 from the arch support area 417. Theseparator wall 420 helps the base layer 405 define the first metatarsalhead pad area 409 and the arch support area 417 for correct placement ofthe first metatarsal head pad and arch support and to keep the firstmetatarsal head pad and arch support components from interfering witheach other. Accordingly, the first metatarsal head pad placed in thefirst metatarsal head pad area 409 is separated from the arch supportarea 417 by the separator wall 420, and as such the first metatarsalhead pad does not lie in the same depression area, or any type ofrecessed area, where the arch support is located.

Alternatively, the bottom surface of base layer 405 may only have one ormore of the defined areas: forefoot wedge area 407, first metatarsalhead pad area 409, heel cushion area 411, rearfoot wedge/heel lift area413, and arch support area 417.

The forefoot wedge area 407 begins just behind the 2^(nd)-5^(th)metatarsal heads and extends proximally to the middle of the foot.

A forefoot wedge is shaped essentially the same as forefoot wedge area407 and is secured therein. The forefoot wedge has a medial edge, alateral edge, a proximal (back) edge and a distal (front) edge. Thedistal edge lies just behind the 2^(nd)-5^(th) metatarsal heads. Themedial edge of the forefoot wedge extends along a line spaced laterallyfrom said medial border of said insole, essentially extending from thedistal edge to the proximal edge. The proximal edge extends from saidmedial edge transversely (or laterally) to said lateral edge, which isspaced slightly medial from said lateral border of said insole. Thelateral edge connects said proximal edge to said distal edge of saidforefoot wedge. FIG. 11 shows the placement of foot bones on the insole.An adhesive or bonding agent may be used to secure the forefoot wedge tothe forefoot wedge area 407.

The shape of the forefoot wedge may vary provided that the alternativeshapes maintain a distal edge approximately at or behind the lessermetatarsal heads and the medial and proximal edges do not interfere withthe first metatarsal head pad area 409 and arch support area 417.

Preferably, for a men's size medium insole, the forefoot wedge has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forthe forefoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The forefoot wedge has a 3° slope that tapers from the thicker lateraledge of about 4 mm thick to the thinner medial edge of about 1 mm thick.The forefoot wedge is used to create a pronation moment around themidfoot joint. This moment helps stabilize the forefoot against therearfoot, reduce supination moments caused by a forefoot valgusdeformity, offload the 1st metatarsophalangeal joint (MTPJ) byincreasing the Ground Reaction Forces (GRF) beneath the lateral aspectof the forefoot and reduce abnormal supination moments around thesubtalar joint.

First metatarsal head pad area 409 is an area in the bottom surface 405Bof the base layer 405 and lies under the first metatarsal head of thefoot. A first metatarsal head pad is shaped essentially the same asfirst metatarsal head pad area 409 and is secured to first metatarsalhead pad area 409. An adhesive or bonding agent may be used to securethe first metatarsal head pad to the first metatarsal head pad area 409.

In use, the first metatarsal head pad remains under the first metatarsalhead (i.e., the medial ball of the user's foot) and moves with it.Removing the pad reduces the GRF beneath the first metatarsal head. Thisenhances propulsion of the foot in wearers with FHL.

The first metatarsal head pad in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area 417, and a lateral edge which is curvilinear orlinear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of the first metatarsalhead pad comes to a point at the proximal and lateral edges. This lengthand width may vary ±5 mm and still maintain the desired performance ofthe first metatarsal head pad. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the firstmetatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area 409. The first metatarsal head pad's basic design is tocreate differential in GRF under the metatarsal heads and allow thefirst metatarsal head to drop below the plane of the other metatarsalswhen the first metatarsal head pad is unattached. Other materials may beused for the first metatarsal head pad such as a Polyurethane (PU),Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the first metatarsal head pad.

The arch support area 417 is located along the longitudinal arch support406 and has a proximal edge end nearest the heel end of the insole andextends toward said toe end of the insole to a distal edge end.Connecting said proximal edge end to said distal edge end is a medialedge and a lateral edge, with said lateral edge having a parabolic-likeshape. The arch support partially wraps up the medial side of base layer405 under the medial longitudinal arch support 406. In general, itapproximately lies in the arch area of the foot or under the talus,navicular, first cuneiform, and proximal part of the first metatarsal.The arch support is shaped essentially the same as arch support area 417and is secured to said arch support area 417 on bottom surface 405B ofbase layer 405. An adhesive or bonding agent may be used to secure thearch support to the arch support area 417.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped depressions that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofthe arch support without sacrificing longitudinal arch support at themiddle and proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer 405 toextend therethrough. The width of each rib is approximately 5 mm. Baselayer 405 is molded so that portions of its material project into therib-shaped openings so that such portions are approximately flush withthe outer surface of the arch support and mechanically lock the archsupport and base layer 405 together. Advantageously, the base layermaterial is also able to bulge through rib-shaped openings when baselayer 405 is compressed (e.g., while walking or running) to provideadditional cushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

When the foot takes up a “neutral” (i.e., neither pronated or supinated)position, the arch support is inactive or applies a gentle supination(anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies ahigher magnitude of GRF against the area beneath the sustentaculum tali(i.e., the proximal arch) increasing the supination (anti-pronation)moment to subtalar joint (i.e., the rearfoot).

The rearfoot wedge/heel lift area 413 is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area 413 isadapted to receive a supplementary pad cushion which can be a rearfootwedge or a heel lift. The rearfoot wedge/heel lift area 413 islongitudinally angled slightly towards the lateral border so that itdoes not interfere with the arch support area 417.

The rearfoot wedge has a 4° slope that tapers from the thicker medialedge of about 4 mm to the thinner lateral edge of about 1 mm. The 4°rearfoot wedge is used to create a supination moment (and reduce thepronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area 417.

Preferably, for a men's size medium insole, the rearfoot wedge has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the rearfoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of therearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forthe rearfoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. The heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area 417.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area 413. A heel cushionmay be secured in the heel cushion area between the base layer and therearfoot wedge or heel lift. The heel cushion may also be secured to theheel cushion area without a rearfoot wedge or heel lift secured thereto.The heel cushion provides shock attenuation and cushioning at heelstrike. Leaving the heel cushion unattached reduces the GRF beneath thecentral heel area to treat certain foot pathologies, and reduces thethickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area 417.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for the heel cushion such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the heel cushion.

In a first preferred embodiment of the present invention, the variouscomponents of an insole which are secured to base layer 405 in the areasdefined by base layer 405 on bottom surface 405B are affixed to baselayer 405 using an appropriate means such as an adhesive or bondingagent.

FIG. 5 illustrates a lateral side view of the insole. The insolepreferably comprises a top sheet 503 and a base layer 505, said baselayer 505 having a top surface 505A secured to said top sheet 503 and anopposite bottom surface 505B. Preferably, said top surface 505A of saidbase layer 505 defines an upwardly-extending portion or metatarsal dome538 (as shown in FIGS. 3, 5, 6, 8 and 9) that lies behind the 2ndthrough 4th plantar metatarsal area of the foot. Base layer 505 alsodefines a longitudinal arch support 506 that extends upwardly along themedial side of the insole to provide extra cushion and support to thearch area of the foot.

Base layer 505 has a raised edge that wraps around the heel and extendspartially along the sides of the foot such that the insole has a heelcup, which conforms to the natural shape of the foot. As seen in FIGS.5-8 and 10, the height of the raised edge is generally higher andthicker on the adjacent the medial border of the insole and is lower andthinner adjacent to the lateral border of the insole. The raised edge isespecially higher along the longitudinal arch area compared to thelateral border.

Base layer 505 is preferably made of foam or other material havingsuitable cushioning properties. Preferably, base layer 505 comprises anEthylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene andvinyl acetate. A preferred EVA foam has a durometer (hardness) of about55-60 Asker C. Other materials may be used for base layer 505 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the base layer 505.

In a preferred embodiment, top surface 505A of base layer 505 is coveredwith top sheet 503, which is preferably a non-woven fabric layer with alow coefficient of friction so as to minimize the possibility ofblisters. In a preferred embodiment, the fabric is treated with anantibacterial agent, which in combination with a moisture barrierreduces odor causing bacteria and fungi. A woven fabric may also beused, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 505 has anapproximate length of 264 mm, an approximate width of 86.5 mm in theforefoot area, an approximate width of 63 mm in the heel area, and anapproximate width of 76.5 through the arch and middle area. These widthsmay vary ±5 mm and still maintain the desired performance of the baselayer 505. The length may vary and may even be shortened by up to 26 mmto fit within the desired shoe. Longer or shorter lengths may also beachieved by altering all the dimensions of the base layerproportionately.

The bottom surface 505B of base layer 505 defines various depressions orareas: a forefoot wedge area 507 in the rear portion of the forefootarea, a first metatarsal head pad area in the area of the firstmetatarsal, a heel cushion area (not visible), rearfoot wedge/heel liftarea 513 in the area of the heel, and an arch support area from themiddle of the insole towards the heel area near the medial side.

Alternatively, the bottom surface 505A of base layer 505 may only haveone or more of the defined areas: forefoot wedge area 507, firstmetatarsal head pad area, heel cushion area, rearfoot wedge/heel liftarea 513, and arch support area.

Metatarsal dome 538 preferably lies behind the 2^(nd)-4^(th) metatarsalheads. Metatarsal dome 538 provides a redistribution of pressure awayfrom the lesser metatarsal heads for general forefoot comfort andrelatively increases the depth of the first metatarsal head pad area toencourage a greater degree of first ray plantarflexion during thepropulsive phase of gait. Preferably the metatarsal dome 538 is anextension of base layer 505. Preferably the metatarsal dome 538 is anextension of base layer 505.

The metatarsal dome 538 preferably has a height of 2.0-3.0 mm above thetop surface 505A. The height may vary ±1 mm, but is not recommended tovary more than that as too little or too much of a metatarsal dome maynot have the desired effects.

Alternatively, metatarsal dome 538 is a conical-like component that issecured to the top surface 505A of base layer 505 in the area behind the2^(nd)-4^(th) metatarsals with the top sheet 503 secured across the topsurface 505A of base layer 505 and either over the metatarsal dome 538or allowing the metatarsal dome 538 to extend therethrough. Anotheralternative is to secure the metatarsal dome 538 to the top sheet 503 inthe area of the 2^(nd)-4^(th) metatarsals.

Preferably the metatarsal dome 538 is made of the same material as baselayer 505. Other materials may be used for metatarsal dome 538 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the metatarsal dome538.

FIG. 6 illustrates a medial side view of the insole. The insolepreferably comprises a top sheet 603 and a base layer 605 having a topsurface 605A secured to said top sheet 603 and an opposite bottomsurface 605B. Base layer 605 also defines a longitudinal arch support606 that extends upwardly along the medial side of the insole to provideextra cushion and support to the arch area of the foot.

Base layer 605 has a raised edge that wraps around the heel and extendspartially along the sides of the foot such that the insole has a heelcup, which conforms to the natural shape of the foot. As seen in FIGS.5-8 and 10, the height of the raised edge is generally higher andthicker on the adjacent the medial border of the insole and is lower andthinner adjacent to the lateral border of the insole. The raised edge isespecially higher along the longitudinal arch area 606 compared to thelateral border.

Base layer 605 is preferably made of foam or other material havingsuitable cushioning properties. Preferably, base layer 605 comprises anEthylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene andvinyl acetate. A preferred EVA foam has a durometer (hardness) of about55-60 Asker C. Other materials may be used for base layer 605 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the base layer 605.

In a preferred embodiment, top surface 605A of base layer 605 is coveredwith top sheet 603, which is preferably a non-woven fabric layer with alow coefficient of friction so as to minimize the possibility ofblisters. In a preferred embodiment, the fabric is treated with anantibacterial agent, which in combination with a moisture barrierreduces odor causing bacteria and fungi. A woven fabric may also beused, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 605 has anapproximate length of 264 mm, an approximate width of 86.5 mm in theforefoot area, an approximate width of 63 mm in the heel area, and anapproximate width of 76.5 through the arch and middle area. These widthsmay vary ±5 mm and still maintain the desired performance of the baselayer 605. The length may vary and may even be shortened by up to 26 mmto fit within the desired shoe. Longer or shorter lengths may also beachieved by altering all the dimensions of the base layerproportionately.

The bottom surface 605B of base layer 605 defines various depressions orareas: a forefoot wedge area in the rear portion of the forefoot area, afirst metatarsal head pad area in the area of the first metatarsal, aheel cushion area (not visible), rearfoot wedge/heel lift area in thearea of the heel, and an arch support area from the middle of the insoletowards the heel area near the medial side.

Base layer 605 also defines a separator wall 620 that divides the firstmetatarsal head pad area 609 from the arch support area 617. Theseparator wall 620 helps the base layer 605 define the first metatarsalhead pad area 609 and the arch support area 617 for correct placement ofthe first metatarsal head pad and arch support and to keep the firstmetatarsal head pad and arch support components from interfering witheach other. Accordingly, the first metatarsal head pad placed in thefirst metatarsal head pad area 609 is separated from the arch supportarea 617 by the separator wall 620, and as such the first metatarsalhead pad does not lie in the same depression area, or any type ofrecessed area, where the arch support is located.

Alternatively, the bottom surface 605A of base layer 605 may only haveone or more of the defined areas: forefoot wedge area, first metatarsalhead pad area 609, heel cushion area, rearfoot wedge/heel lift area, andarch support area 617.

Metatarsal dome 638 preferably lies behind the 2^(nd)-4^(th) metatarsalheads. Metatarsal dome 638 provides a redistribution of pressure awayfrom the lesser metatarsal heads for general forefoot comfort andrelatively increases the depth of the first metatarsal head pad area toencourage a greater degree of first ray plantarflexion during thepropulsive phase of gait. Preferably the metatarsal dome 638 is anextension of base layer 605. Preferably the metatarsal dome 638 is anextension of base layer 605.

The metatarsal dome 638 preferably has a height of 2.0-3.0 mm above thetop surface 605A. The height may vary ±1 mm, but is not recommended tovary more than that as too little or too much of a metatarsal dome maynot have the desired effects.

Alternatively, metatarsal dome 638 is a conical-like component that issecured to the top surface 605A of base layer 605 in the area behind the2^(nd)-4^(th) metatarsals with the top sheet 603 secured across the topsurface 605A of base layer 605 and either over the metatarsal dome 638or allowing the metatarsal dome 638 to extend therethrough. Anotheralternative is to secure the metatarsal dome 638 to the top sheet 603 inthe area of the 2^(nd)-4^(th) metatarsals.

Preferably the metatarsal dome 638 is made of the same material as baselayer 605. Other materials may be used for metatarsal dome 638 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the metatarsal dome638.

A back and medial edge of a first metatarsal head pad extends slightlyup the medial side of the insole. The first metatarsal head pad islocated under the first metatarsal head of the foot forward of the archsupport.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of first metatarsal headpad comes to a point at the proximal and lateral edges. This length andwidth may vary ±5 mm and still maintain the desired performance of thefirst metatarsal head pad. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the first metatarsalhead pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area 609. The first metatarsal head pad's basic design is tocreate differential in GRF under the metatarsal heads and allow thefirst metatarsal head to drop below the plane of the other metatarsalswhen first metatarsal head pad is unattached. Other materials may beused for first metatarsal head pad such as a Polyurethane (PU),Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the first metatarsal head pad.

The arch support area 617 is located along the longitudinal arch support606 and has a proximal edge end nearest the heel end of the insole andextends toward said toe end of the insole to a distal edge end.Connecting said proximal edge end to said distal edge end is a medialedge and a lateral edge, with said lateral edge having a parabolic-likeshape. The arch support partially wraps up the medial side of base layer605 under the medial longitudinal arch support 606. In general, itapproximately lies in the arch area of the foot or under the talus,navicular, first cuneiform, and proximal part of the first metatarsal.The arch support is shaped essentially the same as arch support area 617and is secured to said arch support area 617 on bottom surface 605B ofbase layer 605. An adhesive or bonding agent may be used to secure thearch support to the arch support area 617.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped openings that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofarch support without sacrificing longitudinal arch support at the middleand proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer 605 toextend therethrough. The width of each rib is approximately 5 mm. Baselayer 605 is molded so that portions of its material project into therib-shaped openings so that such portions are approximately flush withthe outer surface of arch support and mechanically lock arch support andbase layer 605 together. Advantageously, the base layer material is alsoable to bulge through rib-shaped openings when base layer 605 iscompressed (e.g., while walking or running) to provide additionalcushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

When the foot takes up a “neutral” (i.e., neither pronated or supinated)position, the arch support is inactive or applies a gentle supination(anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies ahigher magnitude of GRF against the area beneath the sustentaculum tali(i.e., the proximal arch) increasing the supination (anti-pronation)moment to subtalar joint (i.e., the rearfoot).

FIG. 7 illustrates a rear view of the insole. The insole preferablycomprises a top sheet 703 and a base layer 705, said base layer 705having a top surface 705A secured to said top sheet 703 and an oppositebottom surface 705B. Base layer 705 also defines a longitudinal archsupport 706 that extends upwardly along the medial side of the insole toprovide extra cushion and support to the arch area of the foot.

Base layer 705 has a raised edge that wraps around the heel and extendspartially along the sides of the foot such that the insole has a heelcup, which conforms to the natural shape of the foot. As seen in FIGS.5-8 and 10, the height of the raised edge is generally higher andthicker on the adjacent the medial border of the insole and is lower andthinner adjacent to the lateral border of the insole. The raised edge isespecially higher along the longitudinal arch area 706 compared to thelateral border.

Base layer 705 is preferably made of foam or other material havingsuitable cushioning properties. Preferably, base layer 705 comprises anEthylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene andvinyl acetate. A preferred EVA foam has a durometer (hardness) of about55-60 Asker C. Other materials may be used for base layer 705 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the base layer 705.

In a preferred embodiment, top surface 705A of base layer 705 is coveredwith top sheet 703, which is preferably a non-woven fabric layer with alow coefficient of friction so as to minimize the possibility ofblisters. In a preferred embodiment, the fabric is treated with anantibacterial agent, which in combination with a moisture barrierreduces odor causing bacteria and fungi. A woven fabric may also beused, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 705 has anapproximate length of 264 mm, an approximate width of 86.5 mm in theforefoot area, an approximate width of 63 mm in the heel area, and anapproximate width of 76.5 through the arch and middle area. These widthsmay vary ±5 mm and still maintain the desired performance of the baselayer 705. The length may vary and may even be shortened by up to 26 mmto fit within the desired shoe. Longer or shorter lengths may also beachieved by altering all the dimensions of the base layerproportionately.

The arch support area 717 is located along the longitudinal arch support706 and has a proximal edge end nearest the heel end of the insole andextends toward said toe end of the insole to a distal edge end.Connecting said proximal edge end to said distal edge end is a medialedge and a lateral edge, with said lateral edge having a parabolic-likeshape. The arch support partially wraps up the medial side of base layer705 under the medial longitudinal arch support 706. In general, itapproximately lies in the arch area of the foot or under the talus,navicular, first cuneiform, and proximal part of the first metatarsal.The arch support is shaped essentially the same as arch support area 717and is secured to said arch support area 717 on bottom surface 705B ofbase layer 705. An adhesive or bonding agent may be used to secure thearch support to the arch support area 717.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped openings that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofarch support without sacrificing longitudinal arch support at the middleand proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer 705 toextend therethrough. The width of each rib is approximately 5 mm. Baselayer 705 is molded so that portions of its material project into therib-shaped openings so that such portions are approximately flush withthe outer surface of arch support and mechanically lock arch support andbase layer 705 together. Advantageously, the base layer material is alsoable to bulge through rib-shaped openings when base layer 705 iscompressed (e.g., while walking or running) to provide additionalcushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

When the foot takes up a “neutral” (i.e., neither pronated or supinated)position, the arch support is inactive or applies a gentle supination(anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies ahigher magnitude of GRF against the area beneath the sustentaculum tali(i.e., the proximal arch) increasing the supination (anti-pronation)moment to subtalar joint (i.e., the rearfoot).

In a first preferred embodiment of the present invention, the variouscomponents of an insole which are secured to base layer 705 in the areasdefined by base layer 705 on bottom surface 705B are affixed to baselayer 705 using an appropriate means such as an adhesive or bondingagent.

Alternatively, the various components can be molded to the base layer705 during fabrication.

FIG. 8 is a longitudinal cross sectional view of the insole of FIG. 4along the middle of the insole. The insole preferably comprises a topsheet 803 and a base layer 805, said base layer 805 having a top surface805A secured to said top sheet 803 and an opposite bottom surface 805B.Preferably, said top surface 805A of said base layer 805 defines anupwardly-extending portion or metatarsal dome 838 (as shown in FIGS. 3,5, 6, 8 and 9) that lies behind the 2nd through 4th plantar metatarsalarea of the foot. Base layer 805 also defines a longitudinal archsupport 806 that extends upwardly along the medial side of the insole toprovide extra cushion and support to the arch area of the foot.

Base layer 805 has a raised edge that wraps around the heel and extendspartially along the sides of the foot such that the insole has a heelcup, which conforms to the natural shape of the foot. As seen in FIGS.5-8 and 10, the height of the raised edge is generally higher andthicker on the adjacent the medial border of the insole and is lower andthinner adjacent to the lateral border of the insole. The raised edge isespecially higher along the longitudinal arch area 806 compared to thelateral border.

Base layer 805 is preferably made of foam or other material havingsuitable cushioning properties. Preferably, base layer 805 comprises anEthylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene andvinyl acetate. A preferred EVA foam has a durometer (hardness) of about55-60 Asker C. Other materials may be used for base layer 805 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the base layer 805.

In a preferred embodiment, top surface 805A of base layer 805 is coveredwith top sheet 803, which is preferably a non-woven fabric layer with alow coefficient of friction so as to minimize the possibility ofblisters. In a preferred embodiment, the fabric is treated with anantibacterial agent, which in combination with a moisture barrierreduces odor causing bacteria and fungi. A woven fabric may also beused, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 805 has anapproximate length of 264 mm, an approximate width of 86.5 mm in theforefoot area, an approximate width of 63 mm in the heel area, and anapproximate width of 76.5 through the arch and middle area. These widthsmay vary ±5 mm and still maintain the desired performance of the baselayer 805. The length may vary and may even be shortened by up to 26 mmto fit within the desired shoe. Longer or shorter lengths may also beachieved by altering all the dimensions of the base layerproportionately.

The bottom surface 805B of base layer 805 defines various depressions orareas: a forefoot wedge area 807 in the rear portion of the forefootarea, a first metatarsal head pad area in the area of the firstmetatarsal, a heel cushion area 811 and rearfoot wedge/heel lift area813 in the area of the heel, and an arch support area from the middle ofthe insole towards the heel area near the medial side.

Alternatively, the bottom surface 805A of base layer 805 may only haveone or more of the defined areas: forefoot wedge area 807, firstmetatarsal head pad area, heel cushion area 811, rearfoot wedge/heellift area 813, and arch support area.

Metatarsal dome 838 preferably lies behind the 2^(nd)-4^(th)metatarsals. Metatarsal dome 838 provides a redistribution of pressureaway from the lesser metatarsals for general forefoot comfort andrelatively increases the depth of the first metatarsal head pad area toencourage a greater degree of first ray plantarflexion during thepropulsive phase of gait. Preferably the metatarsal dome 838 is anextension of base layer 805.

The metatarsal dome 838 preferably has a height of 2.0-3.0 mm above thetop surface 805A. The height may vary ±1 mm, but is not recommended tovary more than that as too little or too much of a metatarsal dome maynot have the desired effects.

Alternatively, metatarsal dome 838 is a conical-like component that issecured to the top surface 805A of base layer 805 in the area behind the2^(nd)-4^(th) metatarsals with the top sheet 803 secured across the topsurface 805A of base layer 805 and either over the metatarsal dome 838or allowing the metatarsal dome 838 to extend therethrough. Anotheralternative is to secure the metatarsal dome 838 to the top sheet 803 inthe area of the 2^(nd)-4^(th) metatarsals.

Preferably the metatarsal dome 838 is made of the same material as baselayer 805. Other materials may be used for metatarsal dome 838 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the metatarsal dome838.

The forefoot wedge area 807 begins just behind the 2^(nd)-5^(th)metatarsal heads and extends proximally to the middle of the foot.

A forefoot wedge is shaped essentially the same as forefoot wedge area807 and is secured therein. The forefoot wedge has a medial edge, alateral edge, a proximal (back) edge and a distal (front) edge. Thedistal edge lies just behind the 2^(nd)-5^(th) metatarsal heads. Themedial edge of the forefoot wedge extends along a line spaced laterallyfrom said medial border of said insole, essentially extending from thedistal edge to the proximal edge. The proximal edge extends from saidmedial edge transversely (or laterally) to said lateral edge, which isspaced slightly medial from said lateral border of said insole. Thelateral edge connects said proximal edge to said distal edge of saidforefoot wedge. FIG. 11 shows the placement of foot bones on the insole.An adhesive or bonding agent may be used to secure the forefoot wedge tothe forefoot wedge area 807.

The forefoot wedge has a 3° slope that tapers from the thicker lateraledge of about 4 mm thick to the thinner medial edge of about 1 mm thick.The forefoot wedge is used to create a pronation moment around themidfoot joint. This moment helps stabilize the forefoot against therearfoot, reduce supination moments caused by a forefoot valgusdeformity, offload the 1st metatarsophalangeal joint (MTPJ) byincreasing the Ground Reaction Forces (GRF) beneath the lateral aspectof the forefoot and reduce abnormal supination moments around thesubtalar joint.

The shape of the forefoot wedge may vary provided that the alternativeshapes maintain a distal edge approximately at or behind the lessermetatarsal heads and the medial and proximal edges do not interfere withthe first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forthe forefoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The rearfoot wedge/heel lift area 813 is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area 813 isadapted to receive a supplementary pad cushion which can be a rearfootwedge or a heel lift. The rearfoot wedge/heel lift area 813 islongitudinally angled slightly towards the lateral border so that itdoes not interfere with the arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medialedge of about 4 mm to the thinner lateral edge of about 1 mm. The 4°rearfoot wedge is used to create a supination moment (and reduce thepronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the rearfoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of therearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forrearfoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

The heel cushion area 811 is located in the heel area of the insolewithin the boundaries of the rearfoot wedge/heel lift area 813. A heelcushion may be secured in the heel cushion area 811 between the baselayer and the rearfoot wedge or heel lift. The heel cushion may also besecured to the heel cushion area 811 without a rearfoot wedge or heellift secured thereto. The heel cushion provides shock attenuation andcushioning at heel strike. Leaving the heel cushion unattached reducesthe GRF beneath the central heel area to treat certain foot pathologies,and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for the heel cushion such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the heel cushion.

In a first preferred embodiment of the present invention, the variouscomponents of an insole which are secured to base layer 805 in the areasdefined by base layer 805 on bottom surface 805B are affixed to baselayer 805 using an appropriate means such as an adhesive or bondingagent.

Alternatively, the various components can be molded to the base layer805 during fabrication.

FIG. 9 illustrates a transverse cross section 9-9 of the insole behindthe metatarsal region as identified in FIGS. 3 and 4. The insolepreferably comprises a top sheet 903 and a base layer 905, said baselayer 905 having a top surface 905A secured to said top sheet 903 and anopposite bottom surface 905B. Preferably, said top surface 905A of saidbase layer 905 defines an upwardly-extending portion or metatarsal dome938 (as shown in FIGS. 3, 5, 6, 8 and 9) that lies behind the 2ndthrough 4th plantar metatarsal area of the foot. Base layer 905 alsodefines a longitudinal arch support that extends upwardly along themedial side of the insole to provide extra cushion and support to thearch area of the foot.

Base layer 905 has a raised edge that wraps around the heel and extendspartially along the sides of the foot such that the insole has a heelcup, which conforms to the natural shape of the foot. As seen in FIGS.5-8 and 10, the height of the raised edge is generally higher andthicker on the adjacent the medial border of the insole and is lower andthinner adjacent to the lateral border of the insole. The raised edge isespecially higher along the longitudinal arch area compared to thelateral border.

Base layer 905 is preferably made of foam or other material havingsuitable cushioning properties. Preferably, base layer 905 comprises anEthylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene andvinyl acetate. A preferred EVA foam has a durometer (hardness) of about55-60 Asker C. Other materials may be used for base layer 905 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the base layer 905.

In a preferred embodiment, top surface 905A of base layer 905 is coveredwith top sheet 903, which is preferably a non-woven fabric layer with alow coefficient of friction so as to minimize the possibility ofblisters. In a preferred embodiment, the fabric is treated with anantibacterial agent, which in combination with a moisture barrierreduces odor causing bacteria and fungi. A woven fabric may also beused, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 905 has anapproximate length of 264 mm, an approximate width of 86.5 mm in theforefoot area, an approximate width of 63 mm in the heel area, and anapproximate width of 76.5 through the arch and middle area. These widthsmay vary ±5 mm and still maintain the desired performance of the baselayer 905. The length may vary and may even be shortened by up to 26 mmto fit within the desired shoe. Longer or shorter lengths may also beachieved by altering all the dimensions of the base layerproportionately.

The bottom surface 905B of base layer 905 defines various depressions orareas: a forefoot wedge area 907 in the rear portion of the forefootarea, a first metatarsal head pad area 909 in the area of the firstmetatarsal, a heel cushion area and rearfoot wedge/heel lift area in thearea of the heel, and an arch support area 917 from the middle of theinsole towards the heel area near the medial side. Base layer 905 alsodefines a separator wall 920 that divides the first metatarsal head padarea 909 from the arch support area 917.

Alternatively, the bottom surface 905A of base layer 905 may only haveone or more of the defined areas: forefoot wedge area 907, firstmetatarsal head pad area 909, heel cushion area, rearfoot wedge/heellift area, and arch support area 917.

Metatarsal dome 938 preferably lies behind the 2^(nd)-4^(th)metatarsals. Metatarsal dome 938 provides a redistribution of pressureaway from the lesser metatarsals for general forefoot comfort andrelatively increases the depth of the first metatarsal head pad area 909to encourage a greater degree of first ray plantarflexion during thepropulsive phase of gait. Preferably the metatarsal dome 938 is anextension of base layer 905.

The metatarsal dome 938 preferably has a height of 2.0-3.0 mm above thetop surface 905A. The height may vary ±1 mm, but is not recommended tovary more than that as too little or too much of a metatarsal dome maynot have the desired effects.

Alternatively, metatarsal dome 938 is a conical-like component that issecured to the top surface 905A of base layer 905 in the area behind the2^(nd)-4^(th) metatarsals with the top sheet 903 secured across the topsurface 905A of base layer 905 and either over the metatarsal dome 938or allowing the metatarsal dome 938 to extend therethrough. Anotheralternative is to secure the metatarsal dome 938 to the top sheet 903 inthe area of the 2^(nd)-4^(th) metatarsals.

Preferably the metatarsal dome 938 is made of the same material as baselayer 905. Other materials may be used for metatarsal dome 938 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the metatarsal dome938.

The forefoot wedge area 907 begins just behind the 2^(nd)-5^(th)metatarsal heads and extends proximally to the middle of the foot.

A forefoot wedge is shaped essentially the same as forefoot wedge area907 and is secured therein. The forefoot wedge has a medial edge, alateral edge, a proximal (back) edge and a distal (front) edge. Thedistal edge lies just behind the 2^(nd)-5^(th) metatarsal heads. Themedial edge of forefoot wedge extends along a line spaced laterally fromsaid medial border of said insole, essentially extending from the distaledge to the proximal edge. The proximal edge extends from said medialedge transversely (or laterally) to said lateral edge, which is spacedslightly medial from said lateral border of said insole. The lateraledge connects said proximal edge to said distal edge of said forefootwedge. FIG. 11 shows the placement of foot bones on the insole. Anadhesive or bonding agent may be used to secure the forefoot wedge tothe forefoot wedge area 907.

The forefoot wedge has a 3° slope that tapers from the thicker lateraledge of about 4 mm thick to the thinner medial edge of about 1 mm thick.The forefoot wedge is used to create a pronation moment around themidfoot joint. This moment helps stabilize the forefoot against therearfoot, reduce supination moments caused by a forefoot valgusdeformity, offload the 1st metatarsophalangeal joint (MTPJ) byincreasing the Ground Reaction Forces (GRF) beneath the lateral aspectof the forefoot and reduce abnormal supination moments around thesubtalar joint.

The shape of the forefoot wedge may vary provided that the alternativeshapes maintain a distal edge approximately at or behind the lessermetatarsal heads and the medial and proximal edges do not interfere withthe first metatarsal head pad area 909 and arch support area 917.

Preferably, for a men's size medium insole, the forefoot wedge has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forthe forefoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

First metatarsal head pad area 909 is an area in the bottom surface 905Bof the base layer 905 and lies under the first metatarsal head of thefoot. The first metatarsal head pad is shaped essentially the same asfirst metatarsal head pad area 909 and is secured to first metatarsalhead pad area 909. An adhesive or bonding agent may be used to securethe first metatarsal head pad to the first metatarsal head pad area 909.

In use, first metatarsal head pad remains under the first metatarsalhead (i.e., the medial ball of the user's foot) and moves with it.Removing the pad reduces the GRF beneath the first metatarsal head. Thisenhances propulsion of the foot in wearers with FHL.

The first metatarsal head pad, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area 917, and a lateral edge which is curvilinear orlinear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of the first metatarsalhead pad comes to a point at the proximal and lateral edges. This lengthand width may vary ±5 mm and still maintain the desired performance ofthe first metatarsal head pad. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the firstmetatarsal head pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area 909. The first metatarsal head pad's basic design is tocreate differential in GRF under the metatarsal heads and allow thefirst metatarsal head to drop below the plane of the other metatarsalswhen the first metatarsal head pad is unattached. Other materials may beused for the first metatarsal head pad such as a Polyurethane (PU),Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the first metatarsal head pad.

The arch support area 917 is located along the longitudinal arch supportand has a proximal edge end nearest the heel end of the insole andextends toward said toe end of the insole to a distal edge end.Connecting said proximal edge end to said distal edge end is a medialedge and a lateral edge, with said lateral edge having a parabolic-likeshape. An arch support partially wraps up the medial side of base layer905 under the medial longitudinal arch support. In general, itapproximately lies in the arch area of the foot or under the talus,navicular, first cuneiform, and proximal part of the first metatarsal.Arch support is shaped essentially the same as arch support area 917 andis secured to said arch support area 917 on bottom surface 905B of baselayer 905. An adhesive or bonding agent may be used to secure the archsupport to the arch support area 917.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped openings that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofarch support without sacrificing longitudinal arch support at the middleand proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer 905 toextend therethrough. The width of each rib is approximately 5 mm. Baselayer 905 is molded so that portions of its material project into therib-shaped openings so that such portions are approximately flush withthe outer surface of the arch support and mechanically lock the archsupport and base layer 905 together. Advantageously, the base layermaterial is also able to bulge through rib-shaped openings when baselayer 905 is compressed (e.g., while walking or running) to provideadditional cushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

When the foot takes up a “neutral” (i.e., neither pronated or supinated)position, the arch support is inactive or applies a gentle supination(anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies ahigher magnitude of GRF against the area beneath the sustentaculum tali(i.e., the proximal arch) increasing the supination (anti-pronation)moment to subtalar joint (i.e., the rearfoot).

FIG. 10 illustrates a transverse cross section 10-10 of the insole heelarea as identified in FIGS. 3 and 4. The insole preferably comprises atop sheet 1003 and a base layer 1005, said base layer 1005 having a topsurface 1005A secured to said top sheet 1003 and an opposite bottomsurface 1005B.

Base layer 1005 has a raised edge that wraps around the heel and extendspartially along the sides of the foot such that the insole has a heelcup, which conforms to the natural shape of the foot. As seen in FIGS.5-8 and 10, the height of the raised edge is generally higher andthicker on the adjacent the medial border of the insole and is lower andthinner adjacent to the lateral border of the insole. The raised edge isespecially higher along the longitudinal arch area compared to thelateral border.

Base layer 1005 is preferably made of foam or other material havingsuitable cushioning properties. Preferably, base layer 1005 comprises anEthylene vinyl acetate (“EVA”) foam which is a copolymer of ethylene andvinyl acetate. A preferred EVA foam has a durometer (hardness) of about55-60 Asker C. Other materials may be used for base layer 1005 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the base layer 1005.

In a preferred embodiment, top surface 1005A of base layer 1005 iscovered with top sheet 1003, which is preferably a non-woven fabriclayer with a low coefficient of friction so as to minimize thepossibility of blisters. In a preferred embodiment, the fabric istreated with an antibacterial agent, which in combination with amoisture barrier reduces odor causing bacteria and fungi. A woven fabricmay also be used, preferably with a low coefficient of friction.

Preferably, for a men's size medium insole, the base layer 1005 has anapproximate length of 264 mm, an approximate width of 86.5 mm in theforefoot area, an approximate width of 63 mm in the heel area, and anapproximate width of 76.5 through the arch and middle area. These widthsmay vary ±5 mm and still maintain the desired performance of the baselayer 1005. The length may vary and may even be shortened by up to 26 mmto fit within the desired shoe. Longer or shorter lengths may also beachieved by altering all the dimensions of the base layerproportionately.

The bottom surface 1005B of base layer 1005 defines various depressionsor areas: a forefoot wedge area in the rear portion of the forefootarea, a first metatarsal head pad area in the area of the firstmetatarsal, a heel cushion area 1011 and rearfoot wedge/heel lift area1013 in the area of the heel, and an arch support area from the middleof the insole towards the heel area near the medial side.

Alternatively, the bottom surface 1005A of base layer 1005 may only haveone or more of the defined areas: forefoot wedge area, first metatarsalhead pad area, heel cushion area 1011, rearfoot wedge/heel lift area1013, and arch support area.

The rearfoot wedge/heel lift area 1013 is located in the heel area ofthe insole, which extends from about the cuboid of the foot proximallyto the heel end of the insole. The rearfoot wedge/heel lift area 1013 isadapted to receive a supplementary pad cushion which can be a rearfootwedge or a heel lift. The rearfoot wedge/heel lift area 1013 islongitudinally angled slightly towards the lateral border so that itdoes not interfere with the arch support area.

The shape of the rearfoot wedge may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the rearfoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of therearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forrearfoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. The heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for theheel lift such as a Polyurethane (PU), Polypropylene (PP), polyethylene(PE), or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

The heel cushion area 1011 is located in the heel area of the insolewithin the boundaries of the rearfoot wedge/heel lift area 1013. A heelcushion may be secured in the heel cushion area 1011 between the baselayer and a rearfoot wedge or heel lift. The heel cushion may also besecured to the heel cushion area 1011 without a rearfoot wedge or heellift secured thereto. The heel cushion provides shock attenuation andcushioning at heel strike. Leaving the heel cushion unattached reducesthe GRF beneath the central heel area to treat certain foot pathologies,and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for the heel cushion such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the heel cushion.

In a first preferred embodiment of the present invention, the variouscomponents of an insole which are secured to base layer 1005 in theareas defined by base layer 1005 on bottom surface 1005B are affixed tobase layer 1005 using an appropriate means such as an adhesive orbonding agent.

Alternatively, the various components can be molded to the base layer1005 during fabrication.

FIG. 11 illustrates the bones of the foot superimposed over a bottomview of the insole of the present invention. The insole areas shown areforefoot pad area 1107, first metatarsal pad area 1109, heel pad area1111, rearfoot wedge/heel lift area 1113, arch support area 1117, andseparating wall 1120. At the heel of the foot is the calcaneus 1170 andforward of the calcaneus 1170 is the talus 1172. Forward of the talus1172 on the medial side is the navicular 1174 and on the lateral side isthe cuboid 1176. Forward of the cuboid 1176 and the navicular 1174 arecuneiforms 1178. Forward of the cuneiforms 1178 and cuboid 1176 are themetatarsals 1180A, 1180B, 1180C, 1180D and 1180E. The first metatarsal1180A is located on the medial side of the foot and the fifth metatarsal1180E is located on the lateral side of the foot. Forward of themetatarsals 1180A-1180E are the proximal phalanges 1182. Forward of theproximal phalanges 1182 are the middle phalanges 1184, and at the end ofeach toe are the distal phalanges 1186.

FIG. 12 shows the bottom view of the insole (similar to FIG. 4) andillustrates the various areas of the insole: hallux area 1251, lessertoe area 1252, first metatarsal area 1253, lesser metatarsal area 1254,distal medial arch area 1255, lateral midfoot area 1256, proximal medialarch area 1257, heel area 1258, forefoot area 1263, toe area 1261,metatarsal area 1262, midfoot area 1264, and rearfoot area 1265. Theinsole areas of the present invention shown are base layer 1205, baselayer bottom surface 1205B, longitudinal arch support 1206, forefoot padarea 1207, first metatarsal pad area 1209, heel pad area 1211, rearfootwedge/heel lift area 1213, arch support area 1217, and separating wall1220.

Forefoot area 1263 comprises toe area 1261 and metatarsal area 1262,encompassing the entire width of the insole from the toe end to justbehind the metatarsals or “balls” of the feet. Toe area 1261, whichcomprises the hallux area 1251 and the lesser toe area 1252, has alength extending from the toe end to a diagonal edge that runs generallybehind the first distal phalange and second through fifth proximalphalanges and forward of the metatarsals. Toe area 1261 has a widthextending from the medial border to the lateral border. Metatarsal area1262, comprising first metatarsal area 1253 and lesser metatarsal area1254, has a length extending from a front diagonal edge, adjacent thediagonal edge of toe area 1261, to a back diagonal edge that generallyruns behind the metatarsals. Metatarsal area 1262 has a width extendingfrom the medial border to the lateral border.

Hallux area 1251 has a length extending from a front edge near the toeend to a back edge near the joint between the first proximal phalangeand first metatarsal and a width extending from the medial border to alateral edge near the second phalanges. Lesser toe area 1252 has alength extending from a front edge near the toe end to a back edge nearthe second through fifth proximal phalanges and a width extending from amedial edge, medial of the second phalanges and adjacent the lateralborder of hallux area 1251, to a lateral edge near the lateral border.The back edge of lesser toe area 1252 runs generally parallel to thesecond through fifth metatarsals.

The first metatarsal area 1253 extends from a front edge forward of thefirst metatarsal and adjacent the back edge of hallux area 1251 to aback edge just behind the first metatarsal and adjacent a front edge ofmidfoot area 1264. The width of first metatarsal area 1253 extends fromthe medial border to a lateral edge near the second metatarsal. Lessermetatarsal area 1254 extends from a front edge forward of the secondthrough fifth metatarsals and adjacent the back edge of lesser toe area1252 or diagonal edge of toe area 1261 to a back edge behind the secondthrough fifth metatarsals and adjacent a front edge of midfoot area1264. The width of lesser metatarsal area 1254 extends from the lateraledge of the first metatarsal area 1253 to the lateral border.

Midfoot area 1264 comprises distal medial arch area 1255 and lateralmidfoot area 1256. Midfoot area 1264 has a front edge adjacent forefootarea 1263 or metatarsal area 1262 and a back edge that runs diagonallyfrom between the talus and navicular on the medial side to just behindthe cuboid on the lateral side. Midfoot area 1264 has a width extendingfrom the medial border to the lateral border.

Distal medial arch area 1255 extends from a front edge just behind thefirst metatarsal and adjacent the back edge of first metatarsal area1253 or back diagonal edge of metatarsal area 1262 to a back edgebetween the talus and navicular. The width of distal medial arch area1255 extends from the medial border to near the middle of the foot.Lateral midfoot area 1256 extends from a front edge just behind thesecond through fifth metatarsals and adjacent the back edge of lessermetatarsal area 1254 or back diagonal edge of metatarsal area 1262 to aback edge just behind the cuboid. The width of lateral midfoot areaextends from near the middle of the foot to the lateral border.

Rearfoot area 1265 comprises proximal medial arch area 1257 and heelarea 1258. Rearfoot area 1265 has a front edge adjacent the back edge ofmidfoot area 1264 and extends proximally to the heel end. Rearfoot area1265 has a width extending from the medial border to the lateral border.

Proximal medial arch area 1257 extends from a front edge between thetalus and navicular or adjacent the front edge of rearfoot area 1265 toa back point along the medial border about midway between the heel endand the talus. The width of proximal medial arch area 1257 extends fromthe medial border to diagonal lateral edge where the diagonal lateraledge extends from about a third of the insole width laterally from themedial border along the front edge of the rearfoot area 1265 to the backpoint of proximal medial arch area 1257.

Heel area 1258 extends from a front edge just behind the cuboid oradjacent the front edge of rearfoot area 1265 to the heel end. The widthof heel area 1258 extends from the lateral diagonal edge of proximalmedial arch area 1257 to the lateral border.

Forefoot wedge area 1207 preferably extends from just behind the lessermetatarsal heads in the lesser metatarsal area 1254 to slightly into thefront of lateral midfoot area 1256. A forefoot wedge is secured to theforefoot wedge area 1207.

The majority of first metatarsal head area 1209 is located in the firstmetatarsal area 1253. Preferably, a front edge of first metatarsal headarea 1209 lies slightly proximal of the front edge of first metatarsalarea 1253 and adjacent forefoot wedge area 1207. First metatarsal headarea 1209 may also extend into the distal medial arch area 1255. Firstmetatarsal head area 1209 also extends into the front lateral portion ofdistal medial arch area 1255. A first metatarsal head pad is secured tothe first metatarsal head area 1209. Separator wall 1220 helps furtherdistinguish the edges of first metatarsal head area 1209 and archsupport area 1217.

Arch support area 1217 is located in the majority of both the distalmedial arch area 1255 and proximal medial arch area 1257. A front edgeof arch support area 1217 is adjacent a back edge of first metatarsalhead area 1209. An arch support is secured to arch support area 1217.Separator wall 1220 helps further distinguish the edges of firstmetatarsal head area 1209 and arch support area 1217.

Rearfoot wedge/heel lift area 1213 is located in the majority of heelarea 1258. The front edge of the rearfoot/heel lift area 1213 bordersthe lateral midfoot area 1256. A portion of the medial edge ofrearfoot/heel lift area 1213 borders the proximal medial arch area 1257.The proximal edge of rearfoot/heel lift area 1213 borders the heel endof the insole. The lateral edge of rearfoot/heel lift area 1213 bordersthe lateral border of the insole. A rearfoot wedge or heel lift issecured to the rearfoot/heel lift area 1213.

Heel cushion area 1211 is located in heel area 1258 with the boundariesof the rearfoot/heel lift area 1213. A heel cushion is secured to theheel cushion area 1211.

FIG. 13A is a bottom (plantar) view of the first metatarsal head pad1310 and FIG. 13B is a medial view of the first metatarsal head pad1310.

First metatarsal head pad area is an area in the bottom surface of thebase layer and lies under the first metatarsal head of the foot. Firstmetatarsal head pad 1310 is shaped essentially the same as firstmetatarsal head pad area and is secured to first metatarsal head padarea. An adhesive or bonding agent may be used to secure the firstmetatarsal head pad 1310 to the first metatarsal head pad area.

In use, first metatarsal head pad 1310 remains under the firstmetatarsal head (i.e., the medial ball of the user's foot) and moveswith it. Removing the pad reduces the GRF beneath the first metatarsalhead. This enhances propulsion of the foot in wearers with FHL.

The first metatarsal head pad 1310, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad 1310 has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad 1310 has a length of approximately 73.5 mm and a width ofapproximately 29.3 mm at the distal edge. The proximal end of firstmetatarsal head pad 1310 comes to a point at the proximal and lateraledges. This length and width may vary ±5 mm and still maintain thedesired performance of the first metatarsal head pad 1310. For differentsized insoles, the dimensions may be achieved by altering all thedimensions of the first metatarsal head pad 1310 proportionately.

Preferably, said first metatarsal head pad 1310 is an EVA material witha hardness of approximately 40-45 Asker C. Alternatively, the hardnessof the first metatarsal head pad can be approximately between 45-55Asker C, or alternatively 55-60 Asker C. The thickness of the firstmetatarsal head pad 1310 is about 2-2.5 mm thick or the depth of thefirst metatarsal head pad area. First metatarsal head pad's 1310 basicdesign is to create differential in GRF under the metatarsal heads andallow the first metatarsal head to drop below the plane of the othermetatarsals when first metatarsal head pad 1310 is unattached. Othermaterials may be used for first metatarsal head pad 1310 such as aPolyurethane (PU), Polypropylene (PP), polyethylene (PE), or gel thatprovides the appropriate hardness and material characteristics tomaintain the overall structure and resilience of the first metatarsalhead pad 1310.

FIG. 14A is a perspective view of a first embodiment of the arch support1418, FIG. 14B is a bottom (plantar) view of a first embodiment of thearch support 1418, FIG. 14C is a rear (proximal) view of a firstembodiment of the arch support 1418, and FIG. 14D is a sectional view ofa first embodiment of the arch support 1418 along line 14D-14D asidentified in FIG. 14B.

The arch support area is located along the longitudinal arch support andhas a proximal edge end nearest the heel end of the insole and extendstoward said toe end of the insole to a distal edge end. Connecting saidproximal edge end to said distal edge end is a medial edge and a lateraledge, with said lateral edge having a parabolic-like shape. Arch support1418 partially wraps up the medial side of the base layer under themedial longitudinal arch support. In general, it approximately lies inthe arch area of the foot or under the talus, navicular, firstcuneiform, and proximal part of the first metatarsal. Arch support 1418is shaped essentially the same as the arch support area and is securedto said arch support area on the bottom surface of the base layer. Anadhesive or bonding agent may be used to secure the arch support 1418 tothe arch support area.

This first embodiment of the arch support defines, from said proximaledge end going toward said distal edge end, a plurality of extendingribs 1418A that extend outwardly from said arch support. This embodimentprovides a rigid support in the arch area. The extending ribs 1418A areapproximately 0.5 mm thick. The width of each extending rib isapproximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support 1418.

For a men's size medium insole, the arch support 1418 is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support 1418.

When the foot takes up a “neutral” (i.e., neither pronated or supinated)position, the arch support is inactive or applies a gentle supination(anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies ahigher magnitude of GRF against the area beneath the sustentaculum tali(i.e., the proximal arch) increasing the supination (anti-pronation)moment to subtalar joint (i.e., the rearfoot).

FIG. 15A is a perspective view of a second embodiment of the archsupport 1518, FIG. 15B is a bottom (plantar) view of a second embodimentof the arch support 1518, FIG. 15C is a rear (proximal) view of a secondembodiment of the arch support 1518, and FIG. 15D is a sectional view ofa second embodiment of the arch support 1518 along line 15D-15D asidentified in FIG. 15B.

The arch support area is located along the longitudinal arch support andhas a proximal edge end nearest the heel end of the insole and extendstoward said toe end of the insole to a distal edge end. Connecting saidproximal edge end to said distal edge end is a medial edge and a lateraledge, with said lateral edge having a parabolic-like shape. Arch support1518 partially wraps up the medial side of the base layer under themedial longitudinal arch support. In general, it approximately lies inthe arch area of the foot or under the talus, navicular, firstcuneiform, and proximal part of the first metatarsal. Arch support 1518is shaped essentially the same as the arch support area and is securedto said arch support area on the bottom surface of the base layer. Anadhesive or bonding agent may be used to secure the arch support 1518 tothe arch support area.

This second embodiment of the arch support defines, from said proximaledge end going toward said distal edge end, a plurality of rib-shapeddepressions 1518C that extend inwardly from said arch support. Thisembodiment provides a flexible support in the arch area. The rib-shapeddepressions 1518C are depressed into the arch support 1518 about 0.5 mm.The width of each rib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions 1518C may be rib-shapedopenings. The rib-shaped openings are defined to allow said base layerto extend therethrough. The width of each rib is approximately 5 mm. Thebase layer is molded so that portions of its material project into therib-shaped openings so that such portions are approximately flush withthe outer surface of arch support 1518 and mechanically lock archsupport 1518 and the base layer together. Advantageously, the base layermaterial is also able to bulge through rib-shaped openings when the baselayer is compressed (e.g., while walking or running) to provideadditional cushioning.

For a men's size medium insole, the arch support 1518 is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support 1518.

When the foot takes up a “neutral” (i.e., neither pronated or supinated)position, the arch support is inactive or applies a gentle supination(anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies ahigher magnitude of GRF against the area beneath the sustentaculum tali(i.e., the proximal arch) increasing the supination (anti-pronation)moment to subtalar joint (i.e., the rearfoot).

FIG. 16A is a perspective view of a third embodiment of the arch support1618, FIG. 16B is a bottom (plantar) view of a third embodiment of thearch support 1618, FIG. 16C is a rear (proximal) view of a thirdembodiment of the arch support 1618, and FIG. 16D is a sectional view ofa third embodiment of the arch support 1618 along line 16D-16D asidentified in FIG. 16B.

The arch support area is located along the longitudinal arch support andhas a proximal edge end nearest the heel end of the insole and extendstoward said toe end of the insole to a distal edge end. Connecting saidproximal edge end to said distal edge end is a medial edge and a lateraledge, with said lateral edge having a parabolic-like shape. Arch support1618 partially wraps up the medial side of the base layer under themedial longitudinal arch support. In general, it approximately lies inthe arch area of the foot or under the talus, navicular, firstcuneiform, and proximal part of the first metatarsal. Arch support 1618is shaped essentially the same as the arch support area and is securedto said arch support area on the bottom surface of the base layer. Anadhesive or bonding agent may be used to secure the arch support 1618 tothe arch support area.

This third embodiment of the arch support comprises a plurality ofextending ribs 1618A that extend outwardly from said arch support, aplurality of essentially level ribs 1618B having a rib outline indentedin said arch support, and a plurality of rib-shaped openings 1618C thatextend inwardly from said arch support. This embodiment provides asemi-flexible or semi-rigid support in the arch area.

The arch support 1618 defines, from said proximal edge end going towardsaid distal edge end, one or more extending ribs 1618A, one or moreessentially level ribs 1618B, and one or more rib-shaped depressions1618C. Preferably, three extending ribs 1618A, three of said essentiallylevel ribs 1618B, and three rib-shaped depressions 1618C are used. Thewidth of each rib is approximately 5 mm. The extending ribs 1618A areapproximately 0.5 mm thick. The rib-shaped depressions 1618C aredepressed into the arch support 1618 about 0.5 mm. The essentially levelribs 1618B have a rib outline approximately 0.5 mm deep

Rib-shaped depressions 1618C improve flexibility at said distal edge endof arch support 1618 without sacrificing longitudinal arch support atthe middle and proximal end of arch support 1618.

The first three rib-shaped depressions 1618C in the distal one-third ofthe arch support 1618 are provided to allow the area immediatelyproximal to the first metatarsal head (i.e., the distal shaft of thefirst metatarsal) to remain flexible in order to encourage unrestrictedplantarflexion of the first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support 1618 (level ribs1618B and extending ribs 1618A) are stiffened by progressively thickertransverse bars to provide improved support to the arch and theapplication of higher magnitudes of anti-pronation GRF into the area ofthe sustentaculum tali when the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately 1-2 mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions 1618C may be rib-shapedopenings. The rib-shaped openings are defined to allow said base layerto extend therethrough. The width of each rib is approximately 5 mm. Thebase layer is molded so that portions of its material project into therib-shaped openings so that such portions are approximately flush withthe outer surface of arch support 1618 and mechanically lock archsupport 1618 and the base layer together. Advantageously, the base layermaterial is also able to bulge through rib-shaped openings when the baselayer is compressed (e.g., while walking or running) to provideadditional cushioning.

For a men's size medium insole, the arch support 1618 is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support 1618.

When the foot takes up a “neutral” (i.e., neither pronated or supinated)position, the arch support is inactive or applies a gentle supination(anti-pronation) moment to the midfoot.

When the foot moves into a pronated position, the arch support applies ahigher magnitude of GRF against the area beneath the sustentaculum tali(i.e., the proximal arch) increasing the supination (anti-pronation)moment to subtalar joint (i.e., the rearfoot).

FIG. 17A is a perspective view of a forefoot wedge 1708, FIG. 17B is abottom (plantar) view of a forefoot wedge 1708, and FIG. 17C is a rear(proximal) view of a forefoot wedge 1708.

The forefoot wedge area begins just behind the 2^(nd)-5^(th) metatarsalheads and extends proximally to the middle of the foot.

Forefoot wedge 1708 is shaped essentially the same as the forefoot wedgearea and is secured therein. Forefoot wedge 1708 has a medial edge, alateral edge, a proximal (back) edge and a distal (front) edge. Thedistal edge lies just behind the 2^(nd)-5^(th) metatarsal heads. Themedial edge of forefoot wedge 1708 extends along a line spaced laterallyfrom said medial border of said insole, essentially extending from thedistal edge to the proximal edge. The proximal edge extends from saidmedial edge transversely (or laterally) to said lateral edge, which isspaced slightly medial from said lateral border of said insole. Thelateral edge connects said proximal edge to said distal edge of saidforefoot wedge. FIG. 11 shows the placement of foot bones on the insole.An adhesive or bonding agent may be used to secure the forefoot wedge1708 to the forefoot wedge area.

The forefoot wedge 1708 has a 3° slope that tapers from the thickerlateral edge of about 4 mm thick to the thinner medial edge of about 1mm thick. The forefoot wedge 1708 is used to create a pronation momentaround the midfoot joint. This moment helps stabilize the forefootagainst the rearfoot, reduce supination moments caused by a forefootvalgus deformity, offload the 1st metatarsophalangeal joint (MTPJ) byincreasing the Ground Reaction Forces (GRF) beneath the lateral aspectof the forefoot and reduce abnormal supination moments around thesubtalar joint.

The shape of the forefoot wedge 1708 may vary provided that thealternative shapes maintain a distal edge approximately at or behind thelesser metatarsal heads and the medial and proximal edges do notinterfere with the first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge 1708 hasa length of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge 1708. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge 1708 proportionately.

Preferably the forefoot wedge 1708 is made of a high-density EVAmaterial with a hardness of about 75-80 Asker C. Other materials may beused for forefoot wedge 1708 such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the forefoot wedge 1708.

FIG. 18A is a perspective view of a heel cushion 1812, FIG. 18B is abottom (plantar) view of a heel cushion 1812, and FIG. 18C is a medialview of a heel cushion 1812.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushion1812 may be secured in the heel cushion area between the base layer andthe rearfoot wedge or heel lift. The heel cushion 1812 may also besecured to the heel cushion area without a rearfoot wedge or heel liftsecured thereto. The heel cushion 1812 provides shock attenuation andcushioning at heel strike. Leaving the heel cushion unattached reducesthe GRF beneath the central heel area to treat certain foot pathologies,and reduces the thickness of the insole to improve shoe fit.

The shape of the heel cushion 1812 may vary provided that thealternative shapes maintain a position within the heel area do notinterfere with the arch support area.

Preferably, for a men's size medium insole, the heel cushion 1812 has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion 1812 and preferably smaller than therearfoot wedge or heel lift. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the heel cushion 1812proportionately.

Preferably the heel cushion 1812 is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Alternatively, the heel cushionmay be a lower density material with a hardness of about 45-50 Asker C,or alternatively a medium density of 50-75 Asker C. Other materials maybe used for heel cushion 1812 such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the heel cushion 1812.

FIG. 19A is a perspective view of a heel lift 1915, FIG. 19B is a bottom(plantar) view of a heel lift 1915, and FIG. 19C is a sectional view ofa heel lift 1915 along line 19C-19C as identified in FIG. 19B.

The rearfoot wedge/heel lift area is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area is adaptedto receive a supplementary pad cushion which can be a rearfoot wedge ora heel lift 1915. The rearfoot wedge/heel lift area is longitudinallyangled slightly towards the lateral border so that it does not interferewith the arch support area.

The heel lift 1915 approximately tapers from a thicker proximal edge ofabout 4 mm to the thinner distal edge of about 1 mm. Heel lift 1915 isused to adjust the insole on a sagittal plane for the management offorefoot and ankle equinus and their associated kinetic and kinematiceffects on the musculoskeletal system of the lower limb or to balance alimb length discrepancy.

The shape of the heel lift 1915 may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel lift 1915 has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel lift 1915. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift 1915 proportionately.

Preferably the heel lift 1915 is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forheel lift 1915 such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel lift 1915.

FIG. 20A is a perspective view of a rearfoot wedge 2014, FIG. 20B is abottom (plantar) view of a rearfoot wedge 2014, and FIG. 20C is asectional view of a rearfoot wedge 2014 along line 20C-20C as identifiedin FIG. 20B.

The rearfoot wedge/heel lift area is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area is adaptedto receive a supplementary pad cushion which can be a rearfoot wedge2014 or a heel lift. The rearfoot wedge/heel lift area is longitudinallyangled slightly towards the lateral border so that it does not interferewith the arch support area.

The rearfoot wedge 2014 has a 4° slope that tapers from the thickermedial edge of about 4 mm to the thinner lateral edge of about 1 mm. The4° rearfoot wedge 2014 is used to create a supination moment (and reducethe pronation moments) around the subtalar joint.

The shape of the rearfoot wedge 2014 may vary provided that thealternative shapes maintain a position within the heel area do notinterfere with the arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge 2014 hasa length of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the rearfoot wedge 2014. For different sized insoles, thedimensions may be achieved by altering all the dimensions of therearfoot wedge 2014 proportionately.

Preferably the rearfoot wedge 2014 is made of a high-density EVAmaterial with a hardness of about 75-80 Asker C. Other materials may beused for rearfoot wedge 2014 such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the forefoot wedge.

The insole described herein may be delivered to a recipient with thecomponents unattached to allow the recipient to attach the desiredcomponents. The insole may also be delivered to a recipient with apredetermined component configuration already attached prior todelivery. Additionally, the invention may allow for a combination of apredetermined component configuration attached to the insole prior todelivery while also providing additional components that may be attachedby the recipient.

All diagnoses can utilize one or more of the described components, andall the components can be attached to various positions on the insole tovary the characteristics of the insole. The Examples below onlyrepresent a recommended set of components for the described diagnosis.The following are examples of everyday scenarios that can be addressedwith the system of the current invention by using one or more of thecomponents in combination with each other:

Example 1

Scenario: Patient reports burning pain beneath the left big toe joint.Intermittent episodes of pain with sports for many years. Worse sincestarting step classes three times a week. Had to pull out of the lastclass due to severe soreness.

Examination: Pain with direct pressure beneath the inflamed firstmetatarsophalangeal joint (MTPJ), especially over the tibial sesamoid.Plantarflexed first metatarsals bilaterally, plus a forefoot valgus onthe left foot.

Diagnosis: Tibial Sesamoiditis.

Treatment: A forefoot wedge may be applied to the left insole to furtherredirect ground reaction forces (GRF) away from the painful firstmetatarsal head. Heel cushions may be applied to maintain the magnitudeof GRF forces beneath the central heel.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments mayneed to be made to the first metatarsal head pads to reduce the GRFforces beneath the first metatarsal heads.

The forefoot wedge area begins just behind the 2^(nd)-5^(th) metatarsalheads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edgeand a distal (front) edge. The distal edge lies just behind the2^(nd)-5^(th) metatarsal heads. The medial edge of forefoot wedgeextends along a line spaced laterally from said medial border of saidinsole, essentially extending from the distal edge to the proximal edge.The proximal edge extends from said medial edge transversely (orlaterally) to said lateral edge, which is spaced slightly medial fromsaid lateral border of said insole. The lateral edge connects saidproximal edge to said distal edge of said forefoot wedge. FIG. 11 showsthe placement of foot bones on the insole. An adhesive or bonding agentmay be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateraledge of about 4 mm thick to the thinner medial edge of about 1 mm thick.The forefoot wedge is used to create a pronation moment around themidfoot joint. This moment helps stabilize the forefoot against therearfoot, reduce supination moments caused by a forefoot valgusdeformity, offload the metatarsophalangeal joint (MTPJ) by increasingthe Ground Reaction Forces (GRF) beneath the lateral aspect of theforefoot and reduce abnormal supination moments around the subtalarjoint.

The shape of the forefoot wedge may vary provided that the alternativeshapes maintain a distal edge approximately at or behind the lessermetatarsal heads and the medial and proximal edges do not interfere withthe first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forforefoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

Example 2

Scenario: Patient reports painful lump on the ball of the left foot.Calluses have been on the soles of both feet for many years, but theleft foot has become increasingly more red, swollen, and painful overthe last three months.

Examination: Area of thick callus with edema and erythema beneath theleft second MTPJ. Bilateral excessive foot pronation with calcanealeversion in static stance and gait. 0° ankle joint dorsiflexionbilaterally. Metatarsus Primus Elevatus on the left foot.

Diagnosis: Plantar Metatarsal Bursitis.

Treatment: The metatarsal dome and cushioned forefoot extension willreduce excessive GRF beneath the 2nd MTPJ. Rigid arch supports andrearfoot wedges may be applied to reduce the excessive pronationmoments. Heel lifts may be used for the ankle equinus if the shoe stylepermits. First metatarsal head pads and heel cushions may be applied tomaintain the magnitude of GRF forces beneath the first metatarsal headsand central heel.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

The rearfoot wedge/heel lift area is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area is adaptedto receive a supplementary pad cushion which can be a rearfoot wedge ora heel lift. The rearfoot wedge/heel lift area is longitudinally angledslightly towards the lateral border so that it does not interfere withthe arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medialedge of about 4 mm to the thinner lateral edge of about 1 mm. The 4°rearfoot wedge is used to create a supination moment (and reduce thepronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the rearfoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of therearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forrearfoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

First metatarsal head pad area is an area in the bottom surface of thebase layer and lies under the first metatarsal head of the foot. Firstmetatarsal head pad is shaped essentially the same as first metatarsalhead pad area and is secured to first metatarsal head pad area. Anadhesive or bonding agent may be used to secure the first metatarsalhead pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of first metatarsal headpad comes to a point at the proximal and lateral edges. This length andwidth may vary ±5 mm and still maintain the desired performance of thefirst metatarsal head pad. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the first metatarsalhead pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area. First metatarsal head pad's basic design is to createdifferential in GRF under the metatarsal heads and allow the firstmetatarsal head to drop below the plane of the other metatarsals whenfirst metatarsal head pad is unattached. Other materials may be used forfirst metatarsal head pad such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between thebase layer and the rearfoot wedge or heel lift.

Example 3

Scenario: Patient reports painful lumps on the outside of the balls ofthe feet.

Examination: Bilateral Intractable Plantar Keratosis (IPK) with swellingand erythema beneath the 5^(th) metatarsal head. Inverted heel positionsin static stance and gait and bilateral forefoot valgus.

Diagnosis: Plantar metatarsal bursitis with overlying IPK.

Treatment: Forefoot wedges should be applied to both insoles to off-loadthe 5^(th) metatarsal heads and to reduce the degree of heel inversion.First metatarsal head pads and heel cushions may be applied to maintainthe magnitude of GRF forces beneath the first metatarsal heads andcentral heel. If symptoms persist, adjust the first metatarsal head padsto enhance the effect of the metatarsal dome and forefoot wedges.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user.

The forefoot wedge area begins just behind the 2^(nd)-5^(th) metatarsalheads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edgeand a distal (front) edge. The distal edge lies just behind the2^(nd)-5^(th) metatarsal heads. The medial edge of forefoot wedgeextends along a line spaced laterally from said medial border of saidinsole, essentially extending from the distal edge to the proximal edge.The proximal edge extends from said medial edge transversely (orlaterally) to said lateral edge, which is spaced slightly medial fromsaid lateral border of said insole. The lateral edge connects saidproximal edge to said distal edge of said forefoot wedge. FIG. 11 showsthe placement of foot bones on the insole. An adhesive or bonding agentmay be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateraledge of about 4 mm thick to the thinner medial edge of about 1 mm thick.The forefoot wedge is used to create a pronation moment around themidfoot joint. This moment helps stabilize the forefoot against therearfoot, reduce supination moments caused by a forefoot valgusdeformity, offload the metatarsophalangeal joint (MTPJ) by increasingthe Ground Reaction Forces (GRF) beneath the lateral aspect of theforefoot and reduce abnormal supination moments around the subtalarjoint.

The shape of the forefoot wedge may vary provided that the alternativeshapes maintain a distal edge approximately at or behind the lessermetatarsal heads and the medial and proximal edges do not interfere withthe first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forforefoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

First metatarsal head pad area is an area in the bottom surface of thebase layer and lies under the first metatarsal head of the foot. Firstmetatarsal head pad is shaped essentially the same as first metatarsalhead pad area and is secured to first metatarsal head pad area. Anadhesive or bonding agent may be used to secure the first metatarsalhead pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of first metatarsal headpad comes to a point at the proximal and lateral edges. This length andwidth may vary ±5 mm and still maintain the desired performance of thefirst metatarsal head pad. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the first metatarsalhead pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area. First metatarsal head pad's basic design is to createdifferential in GRF under the metatarsal heads and allow the firstmetatarsal head to drop below the plane of the other metatarsals whenfirst metatarsal head pad is unattached. Other materials may be used forfirst metatarsal head pad such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the first metatarsal head pad.

Example 4

Scenario: Patient reports soreness beneath the right big toe at the endof a long day at work. Cushioned insoles help but not enough.

Examination: Inflamed callous beneath the interphalangeal joint (IPJ) ofboth halluces, with the right being greater than the left. Excessivefoot pronantion in static stance and gait with an everted right heel instatic stance and a flexible plantarflexed first metatarsal on the rightfoot. Functional Hallux Limitus (FHL) on the right foot evidenced by astiff right 1^(st) MTPJ with Hubscher Maneuver.

Treatment: Rearfoot wedges and arch supports may be applied to patienttolerance to counteract the excessive pronation moments may be appliedto the right insole. First metatarsal head pad may be applied to theleft insole. Heel cushions may be added to maintain the magnitude of GRFforces beneath central heels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the first metatarsal head pad of the right insole toreduce the GRF forces beneath the first metatarsal head.

The rearfoot wedge/heel lift area is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area is adaptedto receive a supplementary pad cushion which can be a rearfoot wedge ora heel lift. The rearfoot wedge/heel lift area is longitudinally angledslightly towards the lateral border so that it does not interfere withthe arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medialedge of about 4 mm to the thinner lateral edge of about 1 mm. The 4°rearfoot wedge is used to create a supination moment (and reduce thepronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the rearfoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of therearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forrearfoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The arch support area is located along the longitudinal arch support andhas a proximal edge end nearest the heel end of the insole and extendstoward said toe end of the insole to a distal edge end. Connecting saidproximal edge end to said distal edge end is a medial edge and a lateraledge, with said lateral edge having a parabolic-like shape. Arch supportpartially wraps up the medial side of base layer under the mediallongitudinal arch support. In general, it approximately lies in the archarea of the foot or under the talus, navicular, first cuneiform, andproximal part of the first metatarsal. Arch support is shapedessentially the same as arch support area and is secured to said archsupport area on bottom surface of base layer. An adhesive or bondingagent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped openings that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofarch support without sacrificing longitudinal arch support at the middleand proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer to extendtherethrough. The width of each rib is approximately 5 mm. Base layer ismolded so that portions of its material project into the rib-shapedopenings so that such portions are approximately flush with the outersurface of arch support and mechanically lock arch support and baselayer together. Advantageously, the base layer material is also able tobulge through rib-shaped openings when base layer is compressed (e.g.,while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between thebase layer and the rearfoot wedge or heel lift.

Example 5

Scenario: Patient reports painful right big toe joint. The right big toeaches in boots at work, but the pain worsens in the evening in softhouse slippers.

Examination: Bilateral hallux abducto-valgus (HAV) with bunion, rightside greater than left. Right 1^(st) MTPJ is sore at end rangedorsiflexion and plantarflexion. Excessive foot pronation with bothheels everted, right greater than left, in static stance and gait. Lessthan 10° ankle joint dorsiflexion bilaterally. 30°-65° halluxdorsiflexion bilaterally. A plantarflexed first ray. A Hubscher Maneuverof <20° on the right.

Diagnosis: Capsolitis right 1^(st) MTPJ.

Treatment: Rearfoot wedges and rigid arch supports may be appliedbilaterally for the excessive foot pronation. First metatarsal head padmay be applied to the left insole. Heel lifts may be applied for theankle equinus if shoe style permits. Heel cushions may be added tomaintain the magnitude of GRF forces beneath central heels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the first metatarsal head pad of the right insole toreduce the GRF forces beneath the first metatarsal head and accommodatethe plantarflexed first ray.

The rearfoot wedge/heel lift area is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area is adaptedto receive a supplementary pad cushion which can be a rearfoot wedge ora heel lift. The rearfoot wedge/heel lift area is longitudinally angledslightly towards the lateral border so that it does not interfere withthe arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medialedge of about 4 mm to the thinner lateral edge of about 1 mm. The 4°rearfoot wedge is used to create a supination moment (and reduce thepronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the rearfoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of therearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forrearfoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

First metatarsal head pad area is an area in the bottom surface of thebase layer and lies under the first metatarsal head of the foot. Firstmetatarsal head pad is shaped essentially the same as first metatarsalhead pad area and is secured to first metatarsal head pad area. Anadhesive or bonding agent may be used to secure the first metatarsalhead pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of first metatarsal headpad comes to a point at the proximal and lateral edges. This length andwidth may vary ±5 mm and still maintain the desired performance of thefirst metatarsal head pad. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the first metatarsalhead pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area. First metatarsal head pad's basic design is to createdifferential in GRF under the metatarsal heads and allow the firstmetatarsal head to drop below the plane of the other metatarsals whenfirst metatarsal head pad is unattached. Other materials may be used forfirst metatarsal head pad such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between thebase layer and the rearfoot wedge or heel lift.

Example 6

Scenario: Patient reports painful left heel for 3 weeks. Patient hasbeen busier around the house in a new pair of flat house slippers.

Examination: Pain with direct pressure to the medial plantar calcanealtuberosity (MPCT) of the left foot. Moderate degree of flexible forefootequinus, left greater than right. A slight reduction in ankle jointdorsiflexion bilaterally. Bilateral plantarflexed first rays, leftgreater than right. A forefoot valgus on the left. Moderately pronatedfeet with the heels vertical in static stance and gait.

Diagnosis: Proximal Plantar Fasciitis.

Treatment: Heel lifts may be used to “balance” the forefoot and ankleequinus' if shoe style permits. A forefoot wedge may be applied to theleft insole. As the degree of abnormal foot pronation is “moderate,”rearfoot wedges may be omitted in the initial prescription to avoidirritation to the MPCT. The longitudinal arch support may be enough toreduce the excessive pronation moments. Heel cushions may be added tomaintain the magnitude of GRF forces beneath the central heels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the first metatarsal head pads to reduce the GRF forcesbeneath the first metatarsal heads.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

The forefoot wedge area begins just behind the 2^(nd)-5^(th) metatarsalheads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edgeand a distal (front) edge. The distal edge lies just behind the2^(nd)-5^(th) metatarsal heads. The medial edge of forefoot wedgeextends along a line spaced laterally from said medial border of saidinsole, essentially extending from the distal edge to the proximal edge.The proximal edge extends from said medial edge transversely (orlaterally) to said lateral edge, which is spaced slightly medial fromsaid lateral border of said insole. The lateral edge connects saidproximal edge to said distal edge of said forefoot wedge. FIG. 11 showsthe placement of foot bones on the insole. An adhesive or bonding agentmay be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateraledge of about 4 mm thick to the thinner medial edge of about 1 mm thick.The forefoot wedge is used to create a pronation moment around themidfoot joint. This moment helps stabilize the forefoot against therearfoot, reduce supination moments caused by a forefoot valgusdeformity, offload the metatarsophalangeal joint (MTPJ) by increasingthe Ground Reaction Forces (GRF) beneath the lateral aspect of theforefoot and reduce abnormal supination moments around the subtalarjoint.

The shape of the forefoot wedge may vary provided that the alternativeshapes maintain a distal edge approximately at or behind the lessermetatarsal heads and the medial and proximal edges do not interfere withthe first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forforefoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

Example 7

Scenario: Patient reports pain on the sole of the left heel. Patient hitthe sole of the heel on a rock while swimming on holiday.

Examination: Palpable mass in the centre of the left heel, painful todirect pressure. Moderate foot pronation in static stance bilaterallyand a left ankle equinus of approximately 0-5°.

Diagnosis: Plantar Calcaneal Bursitis.

Treatment: The longitudinal arch support may be enough to reduceexcessive pronation moments and redistribute GRF away from the left heeland into the arch, otherwise use an arch support. A heel cushion may beapplied to the right insole. The left insole goes without the heelcushion to reduce the magnitude of GRF beneath the central heel.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the heel cushion of the left insole to reduce the GRFforces beneath the central heel.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

Example 8

Scenario: Patient reports a painful left ankle. Patient has had flatfeet for many years, but severe left ankle pain for last 2 months.

Examination: Patient points to the region of the anterior talofibularligament (ATFL) on the left ankle as the site of pain. Palpation of theligamentous attachments of the ATFL fails to elite pain, but forcefulpassive pronation of the foot does. Severe foot pronation with medialand plantar “subluxation” of the talus on the navicular, left greaterthan right. There is no ankle joint dorsiflexion beyond 90° with theleg.

Diagnosis: Sinus Tarsitis.

Treatment: Flexible arch supports and rearfoot wedges may be applied toreduce the excessive pronation and to reduce the magnitude ofcompression force at the sinus tarsi. Heel lifts may be applied for theankle equinus if shoe style permits. Heel cushions and first metatarsalhead pads may be applied to maintain the magnitude of GRF forces beneaththe first metatarsal heads and central heels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the first metatarsal head pads to reduce the GRF forcesbeneath the first metatarsal heads.

The arch support area is located along the longitudinal arch support andhas a proximal edge end nearest the heel end of the insole and extendstoward said toe end of the insole to a distal edge end. Connecting saidproximal edge end to said distal edge end is a medial edge and a lateraledge, with said lateral edge having a parabolic-like shape. Arch supportpartially wraps up the medial side of base layer under the mediallongitudinal arch support. In general, it approximately lies in the archarea of the foot or under the talus, navicular, first cuneiform, andproximal part of the first metatarsal. Arch support is shapedessentially the same as arch support area and is secured to said archsupport area on bottom surface of base layer. An adhesive or bondingagent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped openings that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofarch support without sacrificing longitudinal arch support at the middleand proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer to extendtherethrough. The width of each rib is approximately 5 mm. Base layer ismolded so that portions of its material project into the rib-shapedopenings so that such portions are approximately flush with the outersurface of arch support and mechanically lock arch support and baselayer together. Advantageously, the base layer material is also able tobulge through rib-shaped openings when base layer is compressed (e.g.,while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

The rearfoot wedge/heel lift area is located in the heel area of theinsole, which extends from about the cuboid of the foot proximally tothe heel end of the insole. The rearfoot wedge/heel lift area is adaptedto receive a supplementary pad cushion which can be a rearfoot wedge ora heel lift. The rearfoot wedge/heel lift area is longitudinally angledslightly towards the lateral border so that it does not interfere withthe arch support area.

The rearfoot wedge has a 4° slope that tapers from the thicker medialedge of about 4 mm to the thinner lateral edge of about 1 mm. The 4°rearfoot wedge is used to create a supination moment (and reduce thepronation moments) around the subtalar joint.

The shape of the rearfoot wedge may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the rearfoot wedge has alength of approximately 71.8 mm and a width of approximately 46.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the rearfoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of therearfoot wedge proportionately.

Preferably the rearfoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forrearfoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

First metatarsal head pad area is an area in the bottom surface of thebase layer and lies under the first metatarsal head of the foot. Firstmetatarsal head pad is shaped essentially the same as first metatarsalhead pad area and is secured to first metatarsal head pad area. Anadhesive or bonding agent may be used to secure the first metatarsalhead pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of first metatarsal headpad comes to a point at the proximal and lateral edges. This length andwidth may vary ±5 mm and still maintain the desired performance of thefirst metatarsal head pad. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the first metatarsalhead pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area. First metatarsal head pad's basic design is to createdifferential in GRF under the metatarsal heads and allow the firstmetatarsal head to drop below the plane of the other metatarsals whenfirst metatarsal head pad is unattached. Other materials may be used forfirst metatarsal head pad such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between thebase layer and the rearfoot wedge or heel lift.

Example 9

Scenario: No instability when walking or training on flat surfaces, butrecurrent inversion sprains of the right ankle on a bumpy pitch.

Examination: Grade 1 right ankle sprain. Retains good proprioception andperoneal strength. Bilateral forefoot valgus right is greater than left,and a plantarflexed first ray on the right foot. The right foot isslightly supinated in static stance and gait.

Diagnosis: Chronic ankle sprain.

Treatment: A forefoot wedge may be applied to both insoles. A firstmetatarsal head pad may be applied to the left insole. The right insolegoes without the first metatarsal head pad to accommodate theplantarflexed first metatarsal.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the heel cushions of both insoles and first metatarsalhead pad of the right insole to reduce the GRF forces beneath thecentral heels of both insoles, reduce the GRF forces beneath the firstmetatarsal head on the right insole and accommodate the plantarflexedfirst metatarsal.

The forefoot wedge area begins just behind the 2^(nd)-5^(th) metatarsalheads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edgeand a distal (front) edge. The distal edge lies just behind the2^(nd)-5^(th) metatarsal heads. The medial edge of forefoot wedgeextends along a line spaced laterally from said medial border of saidinsole, essentially extending from the distal edge to the proximal edge.The proximal edge extends from said medial edge transversely (orlaterally) to said lateral edge, which is spaced slightly medial fromsaid lateral border of said insole. The lateral edge connects saidproximal edge to said distal edge of said forefoot wedge. FIG. 11 showsthe placement of foot bones on the insole. An adhesive or bonding agentmay be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateraledge of about 4 mm thick to the thinner medial edge of about 1 mm thick.The forefoot wedge is used to create a pronation moment around themidfoot joint. This moment helps stabilize the forefoot against therearfoot, reduce supination moments caused by a forefoot valgusdeformity, offload the metatarsophalangeal joint (MTPJ) by increasingthe Ground Reaction Forces (GRF) beneath the lateral aspect of theforefoot and reduce abnormal supination moments around the subtalarjoint.

The shape of the forefoot wedge may vary provided that the alternativeshapes maintain a distal edge approximately at or behind the lessermetatarsal heads and the medial and proximal edges do not interfere withthe first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forforefoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

First metatarsal head pad area is an area in the bottom surface of thebase layer and lies under the first metatarsal head of the foot. Firstmetatarsal head pad is shaped essentially the same as first metatarsalhead pad area and is secured to first metatarsal head pad area. Anadhesive or bonding agent may be used to secure the first metatarsalhead pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of first metatarsal headpad comes to a point at the proximal and lateral edges. This length andwidth may vary ±5 mm and still maintain the desired performance of thefirst metatarsal head pad. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the first metatarsalhead pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area. First metatarsal head pad's basic design is to createdifferential in GRF under the metatarsal heads and allow the firstmetatarsal head to drop below the plane of the other metatarsals whenfirst metatarsal head pad is unattached. Other materials may be used forfirst metatarsal head pad such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the first metatarsal head pad.

Example 10

Scenario: Patient reports painful Achilles tendons. Pain on and off for5 years despite a conscientious stretching program. Pain became worse 2years ago during training for the National Schools Championship.Physiotherapist prescribed ice, rest, and gave ultrasound 3 times aweek, which has helped.

Examination: Both Achilles tendons are tender to direct pressure andappear moderately “thickened”. Passive and active ankle jointdorsiflexion causes pain immediately above the calcaneal insertion andthere is tenderness at the myotendinous junction. A moderately cavusfoot type with less than 10° of ankle joint dorsiflexion, forefootequinus, plantarflexed first ray, and forefoot valgus bilaterally.

Diagnosis: Achilles tendonitis.

Treatment: Heel lifts for the ankle and forefoot equinus and forefootwedges may be applied. Heel cushions may be applied to maintain themagnitude of GRF forces beneath the central heels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the first metatarsal head pads to reduce the GRF forcesbeneath the first metatarsal heads to accommodate the plantarflexedfirst metatarsals.

The forefoot wedge area begins just behind the 2^(nd)-5^(th) metatarsalheads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edgeand a distal (front) edge. The distal edge lies just behind the2^(nd)-5^(th) metatarsal heads. The medial edge of forefoot wedgeextends along a line spaced laterally from said medial border of saidinsole, essentially extending from the distal edge to the proximal edge.The proximal edge extends from said medial edge transversely (orlaterally) to said lateral edge, which is spaced slightly medial fromsaid lateral border of said insole. The lateral edge connects saidproximal edge to said distal edge of said forefoot wedge. FIG. 11 showsthe placement of foot bones on the insole. An adhesive or bonding agentmay be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateraledge of about 4 mm thick to the thinner medial edge of about 1 mm thick.The forefoot wedge is used to create a pronation moment around themidfoot joint. This moment helps stabilize the forefoot against therearfoot, reduce supination moments caused by a forefoot valgusdeformity, offload the metatarsophalangeal joint (MTPJ) by increasingthe Ground Reaction Forces (GRF) beneath the lateral aspect of theforefoot and reduce abnormal supination moments around the subtalarjoint.

The shape of the forefoot wedge may vary provided that the alternativeshapes maintain a distal edge approximately at or behind the lessermetatarsal heads and the medial and proximal edges do not interfere withthe first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forforefoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between thebase layer and the rearfoot wedge or heel lift.

Example 11

Scenario: Patient reports shin splints. Patient has had a few episodesover the last few years, usually in the high season when the hotel getsbusy.

Examination: Pain to direct pressure immediately posterior to the medialborders of the tibae, immediately proximal to the medial malleolus, andwith foot inversion against resistance. Bilateral excessive footpronation (with calcaneal eversion) in static stance and gait, less than10° ankle joint dorsiflexion, and Functional hallux limitus (FHL) withless than 10° dorsiflexion of both halluces with Hubscher Maneuver.

Diagnosis: Tibialis Posterior Tendinitis.

Treatment: Heel lifts may be applied for the ankle joint equinus. Rigidarch supports and rearfoot wedges may be applied to reduce the magnitudeof excessive pronation moments. If the patient complains of archirritation, the rigid arch supports should be replaced with thesemi-flexible arch supports which may be more easily tolerated. Heelcushions may be applied to maintain the magnitude of GRF forces beneaththe central heels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the first metatarsal head pads to reduce the GRF forcesbeneath the first metatarsal heads.

The arch support area is located along the longitudinal arch support andhas a proximal edge end nearest the heel end of the insole and extendstoward said toe end of the insole to a distal edge end. Connecting saidproximal edge end to said distal edge end is a medial edge and a lateraledge, with said lateral edge having a parabolic-like shape. Arch supportpartially wraps up the medial side of base layer under the mediallongitudinal arch support. In general, it approximately lies in the archarea of the foot or under the talus, navicular, first cuneiform, andproximal part of the first metatarsal. Arch support is shapedessentially the same as arch support area and is secured to said archsupport area on bottom surface of base layer. An adhesive or bondingagent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped openings that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofarch support without sacrificing longitudinal arch support at the middleand proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer to extendtherethrough. The width of each rib is approximately 5 mm. Base layer ismolded so that portions of its material project into the rib-shapedopenings so that such portions are approximately flush with the outersurface of arch support and mechanically lock arch support and baselayer together. Advantageously, the base layer material is also able tobulge through rib-shaped openings when base layer is compressed (e.g.,while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between thebase layer and the rearfoot wedge or heel lift.

Example 12

Scenario: Patient tripped off a curb. Pain on the outside of the leftshin following a mild ankle sprain. Outside of the left shin becamepainful 2 days later. No previous treatment.

Examination: Tenderness along the course of the peroneal tendons at thelower third of the left leg. Moderately high arch; cavus feet withforefoot valgus bilaterally. Platarflexed first rays. Slightly invertedheels in relaxed stance.

Diagnosis: Peroneal tendinitis.

Treatment: Forefoot wedges may be applied to reduce the tensile forcethrough the peroneals. Heel cushions may be applied to maintain themagnitude of GRF forces beneath the central heels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the first metatarsal head pads to reduce the GRF forcesbeneath the first metatarsal heads and accommodate the plantarflexedfirst metatarsals.

The forefoot wedge area begins just behind the 2^(nd)-5^(th) metatarsalheads and extends proximally to the middle of the foot.

Forefoot wedge has a medial edge, a lateral edge, a proximal (back) edgeand a distal (front) edge. The distal edge lies just behind the2^(nd)-5^(th) metatarsal heads. The medial edge of forefoot wedgeextends along a line spaced laterally from said medial border of saidinsole, essentially extending from the distal edge to the proximal edge.The proximal edge extends from said medial edge transversely (orlaterally) to said lateral edge, which is spaced slightly medial fromsaid lateral border of said insole. The lateral edge connects saidproximal edge to said distal edge of said forefoot wedge. FIG. 11 showsthe placement of foot bones on the insole. An adhesive or bonding agentmay be used to secure the forefoot wedge to the forefoot wedge area.

The forefoot wedge has a 3° slope that tapers from the thicker lateraledge of about 4 mm thick to the thinner medial edge of about 1 mm thick.The forefoot wedge is used to create a pronation moment around themidfoot joint. This moment helps stabilize the forefoot against therearfoot, reduce supination moments caused by a forefoot valgusdeformity, offload the metatarsophalangeal joint (MTPJ) by increasingthe Ground Reaction Forces (GRF) beneath the lateral aspect of theforefoot and reduce abnormal supination moments around the subtalarjoint.

The shape of the forefoot wedge may vary provided that the alternativeshapes maintain a distal edge approximately at or behind the lessermetatarsal heads and the medial and proximal edges do not interfere withthe first metatarsal head pad area and arch support area.

Preferably, for a men's size medium insole, the forefoot wedge has alength of approximately 55.9 mm and a width of approximately 51.3 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the forefoot wedge. For different sized insoles, thedimensions may be achieved by altering all the dimensions of theforefoot wedge proportionately.

Preferably the forefoot wedge is made of a high-density EVA materialwith a hardness of about 75-80 Asker C. Other materials may be used forforefoot wedge such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the forefoot wedge.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

Example 13

Scenario: Patient reports pain under the right knee cap when playingbasketball, when going up and down stairs, and when rising from a seatedposition. Has been taking Ibuprofen PRN, which causes acid reflux.Physiotherapist has prescribed a knee support with patella aperture andVMO strengthening exercises, which has helped. Patient mentions shealways stands with the right knee flexed.

Examination: Pain on compression of the right patella femoral joint andthe Patella Apprehension Test. Excessive pronation (with calcanealeversion) of the right foot only in static stance. Plantarflexed firstmetatarsal on the right. Reduced right hallux dorsiflexion with theHubscher Maneuver. Short left leg by approximately 8.0 mm.

Diagnosis: Patello-femoral pain syndrome (PFPS).

Treatment: A rigid arch support and a rearfoot wedge may be applied tothe right insole. A first metatarsal head pad should be applied to theleft insole only so that the right insole can accommodate theplantarflexed first metatarsal. A heel lift may be applied to the leftinsole to correct for the limb-length discrepancy. Heel cushions may beapplied to maintain the magnitude of GRF forces beneath the centralheels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the first metatarsal head pad of the right insole toreduce the GRF forces beneath the first metatarsal head and accommodatethe plantarflexed first metatarsal.

The arch support area is located along the longitudinal arch support andhas a proximal edge end nearest the heel end of the insole and extendstoward said toe end of the insole to a distal edge end. Connecting saidproximal edge end to said distal edge end is a medial edge and a lateraledge, with said lateral edge having a parabolic-like shape. Arch supportpartially wraps up the medial side of base layer under the mediallongitudinal arch support. In general, it approximately lies in the archarea of the foot or under the talus, navicular, first cuneiform, andproximal part of the first metatarsal. Arch support is shapedessentially the same as arch support area and is secured to said archsupport area on bottom surface of base layer. An adhesive or bondingagent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped openings that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofarch support without sacrificing longitudinal arch support at the middleand proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer to extendtherethrough. The width of each rib is approximately 5 mm. Base layer ismolded so that portions of its material project into the rib-shapedopenings so that such portions are approximately flush with the outersurface of arch support and mechanically lock arch support and baselayer together. Advantageously, the base layer material is also able tobulge through rib-shaped openings when base layer is compressed (e.g.,while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

First metatarsal head pad area is an area in the bottom surface of thebase layer and lies under the first metatarsal head of the foot. Firstmetatarsal head pad is shaped essentially the same as first metatarsalhead pad area and is secured to first metatarsal head pad area. Anadhesive or bonding agent may be used to secure the first metatarsalhead pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of first metatarsal headpad comes to a point at the proximal and lateral edges. This length andwidth may vary ±5 mm and still maintain the desired performance of thefirst metatarsal head pad. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the first metatarsalhead pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area. First metatarsal head pad's basic design is to createdifferential in GRF under the metatarsal heads and allow the firstmetatarsal head to drop below the plane of the other metatarsals whenfirst metatarsal head pad is unattached. Other materials may be used forfirst metatarsal head pad such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between thebase layer and the rearfoot wedge or heel lift.

Example 14

Scenario: Patient reports pain and swelling over the insides of bothshins, worse when running downhill. Insidious onset. No history of kneetwists or direct trauma.

Examination: Pain to direct pressure over the medial femoral condylesand slightly inferior to the joint line at the attachment of PesAnserinus bilaterally. Moderate forefoot equinus. Excessive footpronation (mostly forefoot abduction) to heel vertical in static stanceand gait. Less than 10° ankle joint dorsiflexion bilaterally.

Diagnosis: Pes Anerinus friction syndrome and enthesitis.

Treatment: Heel lifts may be applied to “balance” the forefoot and ankleequinus. The incorporated medial longitudinal arch support may be enoughto reduce the associated excessive foot pronation in the first instance,although an arch support to patient tolerance and rearfoot wedge shouldbe considered to reduce the excessive forefoot abduction. Heel cushionsand first metatarsal head pads may be applied to maintain the magnitudeof GRF forces beneath the first metatarsal heads and central heels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user.

The arch support area is located along the longitudinal arch support andhas a proximal edge end nearest the heel end of the insole and extendstoward said toe end of the insole to a distal edge end. Connecting saidproximal edge end to said distal edge end is a medial edge and a lateraledge, with said lateral edge having a parabolic-like shape. Arch supportpartially wraps up the medial side of base layer under the mediallongitudinal arch support. In general, it approximately lies in the archarea of the foot or under the talus, navicular, first cuneiform, andproximal part of the first metatarsal. Arch support is shapedessentially the same as arch support area and is secured to said archsupport area on bottom surface of base layer. An adhesive or bondingagent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped openings that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofarch support without sacrificing longitudinal arch support at the middleand proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer to extendtherethrough. The width of each rib is approximately 5 mm. Base layer ismolded so that portions of its material project into the rib-shapedopenings so that such portions are approximately flush with the outersurface of arch support and mechanically lock arch support and baselayer together. Advantageously, the base layer material is also able tobulge through rib-shaped openings when base layer is compressed (e.g.,while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

First metatarsal head pad area is an area in the bottom surface of thebase layer and lies under the first metatarsal head of the foot. Firstmetatarsal head pad is shaped essentially the same as first metatarsalhead pad area and is secured to first metatarsal head pad area. Anadhesive or bonding agent may be used to secure the first metatarsalhead pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of first metatarsal headpad comes to a point at the proximal and lateral edges. This length andwidth may vary ±5 mm and still maintain the desired performance of thefirst metatarsal head pad. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the first metatarsalhead pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area. First metatarsal head pad's basic design is to createdifferential in GRF under the metatarsal heads and allow the firstmetatarsal head to drop below the plane of the other metatarsals whenfirst metatarsal head pad is unattached. Other materials may be used forfirst metatarsal head pad such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the first metatarsal head pad.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between thebase layer and the rearfoot wedge or heel lift.

Example 15

Scenario: Patient reports pain on the outside of the right knee. Painstarted on a skiing holiday where the lateral aspect of right kneebecame painful on side stepping. Pain now continues during aerobicsclasses.

Examination: Pain is produced with direct pressure to the lateralfemoral condyle and proximally along 4-5 cm of the iliotibial band(ITB). Excessive foot pronation with calcaneal eversion in static stancecausing the legs to internally rotate as evidenced by “squinting”patellae. There is no ankle joint equinus.

Diagnosis: ITB friction syndrome and tendinitis.

Treatment: As the symptoms are acute in nature, the patient may begin towear the insoles may only have the first metatarsal pads and heelcushions applied to see if the incorporated medial longitudinal archsupport reduces the symptoms. If the symptoms persist, an arch supportmay be added to both insoles along with a rearfoot wedge to the rightinsole to reduce the pronation moments.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user.

First metatarsal head pad area is an area in the bottom surface of thebase layer and lies under the first metatarsal head of the foot. Firstmetatarsal head pad is shaped essentially the same as first metatarsalhead pad area and is secured to first metatarsal head pad area. Anadhesive or bonding agent may be used to secure the first metatarsalhead pad to the first metatarsal head pad area.

The first metatarsal head pad, in shape, is a slightly irregularpolygonal shape. Preferably, said first metatarsal head pad has anessentially linear distal edge, a slightly curvilinear medial edge whichfollows the curve of the medial border of the insole, a proximal edgewhich is curved or angled to follow the shape of the metatarsal edge ofarch support area, and a lateral edge which is curvilinear or linear.

Preferably, for a men's size medium insole, the first metatarsal headpad has a length of approximately 73.5 mm and a width of approximately29.3 mm at the distal edge. The proximal end of first metatarsal headpad comes to a point at the proximal and lateral edges. This length andwidth may vary ±5 mm and still maintain the desired performance of thefirst metatarsal head pad. For different sized insoles, the dimensionsmay be achieved by altering all the dimensions of the first metatarsalhead pad proportionately.

Preferably, said first metatarsal head pad is an EVA material with ahardness of approximately 40-45 Asker C. Alternatively, the hardness ofthe first metatarsal head pad can be approximately between 45-55 AskerC, or alternatively 55-60 Asker C. The thickness of the first metatarsalhead pad is about 2-2.5 mm thick or the depth of the first metatarsalhead pad area. First metatarsal head pad's basic design is to createdifferential in GRF under the metatarsal heads and allow the firstmetatarsal head to drop below the plane of the other metatarsals whenfirst metatarsal head pad is unattached. Other materials may be used forfirst metatarsal head pad such as a Polyurethane (PU), Polypropylene(PP), polyethylene (PE), or gel that provides the appropriate hardnessand material characteristics to maintain the overall structure andresilience of the first metatarsal head pad.

Example 16

Scenario: Patient reported lower back pain when walking, exacerbatedwhen jogging over one mile, which improves with rest. Prior orthopedicexamination and imaging reveals no lesion or pathological condition.Prior diagnosis was idiopathic low-back pain. Core stability exercisesprescribed by a physiotherapist have reduced the symptoms byapproximately 50%.

Examination: Patient points to the area of the lumbar spine as the siteof pain. A short left leg of approximately 8.0-9.0 mm causing a pelvictilt to the left in static stance. Pronated feet bilaterally witheverted heels, left greater than right. A marked plantarflexed first rayon the left foot with restricted left hallux dorsiflexion with theHubscher maneuver reveals a Functional Hallux Limitus (FHL).

Diagnosis: Gait related low-back pain.

Treatment: A heel lift (with caution and close monitoring) may beapplied to the left insole to reduce the pelvic tilt. Arch supports (topatient tolerance) and rearfoot wedges may be applied to reduce theexcessive pronation moments. A first metatarsal head pad may be appliedto the right insole. Left insole may go without the first metatarsalhead pad to improve the hallux dorsiflexion. Heel cushions may beapplied to maintain the magnitude of GRF forces beneath the centralheels.

Alternatively, the insoles may be delivered to the user with the heelcushions and first metatarsal head pads pre-attached before applicationof additional components by the user. For this example, adjustments needto be made to the first metatarsal head pad of the left insole to reducethe GRF forces beneath the first metatarsal head and improve halluxdorsiflexion.

The arch support area is located along the longitudinal arch support andhas a proximal edge end nearest the heel end of the insole and extendstoward said toe end of the insole to a distal edge end. Connecting saidproximal edge end to said distal edge end is a medial edge and a lateraledge, with said lateral edge having a parabolic-like shape. Arch supportpartially wraps up the medial side of base layer under the mediallongitudinal arch support. In general, it approximately lies in the archarea of the foot or under the talus, navicular, first cuneiform, andproximal part of the first metatarsal. Arch support is shapedessentially the same as arch support area and is secured to said archsupport area on bottom surface of base layer. An adhesive or bondingagent may be used to secure the arch support to the arch support area.

One embodiment of the arch support defines, from said proximal edge endgoing toward said distal edge end, a plurality of extending ribs thatextend outwardly from said arch support. This embodiment provides arigid support in the arch area. The extending ribs are approximately 0.5mm thick. The width of each extending rib is approximately 5 mm.

This first embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 90-100 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A second embodiment of the arch support defines, from said proximal edgeend going toward said distal edge end, a plurality of rib-shapeddepressions that extend inwardly from said arch support. This embodimentprovides a flexible support in the arch area. The rib-shaped depressionsare depressed into the arch support about 0.5 mm. The width of eachrib-shaped depression is approximately 5 mm.

This second embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Shore A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

A third embodiment of the arch support comprises a plurality ofextending ribs that extend outwardly from said arch support, a pluralityof essentially level ribs having a rib outline indented in said archsupport, and a plurality of rib-shaped openings that extend inwardlyfrom said arch support. This embodiment provides a semi-flexible orsemi-rigid support in the arch area.

The arch support defines, from said proximal edge end going toward saiddistal edge end, one or more extending ribs, one or more essentiallylevel ribs, and one or more rib-shaped depressions. Preferably, threeextending ribs, three of said essentially level ribs, and threerib-shaped depressions are used. The width of each rib is approximately5 mm. The extending ribs are approximately 0.5 mm thick. The rib-shapeddepressions are depressed into the arch support about 0.5 mm. Theessentially level ribs have a rib outline approximately 0.5 mm deep

Rib-shaped depressions improve flexibility at said distal edge end ofarch support without sacrificing longitudinal arch support at the middleand proximal end of arch support.

The first three rib-shaped depressions in the distal one-third of thearch support are provided to allow the area immediately proximal to thefirst metatarsal head (i.e., the distal shaft of the first metatarsal)to remain flexible in order to encourage unrestricted plantarflexion ofthe first ray during the propulsive phase of gait.

The central and proximal two-thirds of the arch support (level ribs andextending ribs) are stiffened by progressively thicker transverse barsto provide improved support to the arch and the application of highermagnitudes of anti-pronation GRF into the area of the sustentaculum taliwhen the foot moves into a pronated position.

This third embodiment is preferably made of a nylon material, forexample Nylon 66, having a hardness of about 80-90 Asker A. Thisthickness of the arch support in the non-rib areas range fromapproximately mm. Other materials may be used such as a Polyurethane(PU), Polypropylene (PP), polyethylene (PE), or gel that provides theappropriate hardness and material characteristics to maintain theoverall structure and resilience of the arch support.

Alternatively, the rib-shaped depressions may be rib-shaped openings.The rib-shaped openings are defined to allow said base layer to extendtherethrough. The width of each rib is approximately 5 mm. Base layer ismolded so that portions of its material project into the rib-shapedopenings so that such portions are approximately flush with the outersurface of arch support and mechanically lock arch support and baselayer together. Advantageously, the base layer material is also able tobulge through rib-shaped openings when base layer is compressed (e.g.,while walking or running) to provide additional cushioning.

For a men's size medium insole, the arch support is approximately104-105 mm long. The width at the widest point, near the middle, isabout 37.5 to 38.5 mm. This length and width may vary ±5 mm and stillmaintain the desired performance of the first arch support.

The heel lift approximately tapers from a thicker proximal edge of about4 mm to the thinner distal edge of about 1 mm. Heel lift is used toadjust the insole on a sagittal plane for the management of forefoot andankle equinus and their associated kinetic and kinematic effects on themusculoskeletal system of the lower limb or to balance a limb lengthdiscrepancy.

The shape of the heel lift may vary provided that the alternative shapesmaintain a position within the heel area do not interfere with the archsupport area.

Preferably, for a men's size medium insole, the heel lift has a lengthof approximately 71.8 mm and a width of approximately 46.9 mm. Thislength and width may vary ±5 mm and still maintain the desiredperformance of the heel lift. For different sized insoles, thedimensions may be achieved by altering all the dimensions of the heellift proportionately.

Preferably the heel lift is made of a high-density EVA material with ahardness of about 75-80 Asker C. Other materials may be used for heellift such as a Polyurethane (PU), Polypropylene (PP), polyethylene (PE),or gel that provides the appropriate hardness and materialcharacteristics to maintain the overall structure and resilience of theheel lift.

The heel cushion area is located in the heel area of the insole withinthe boundaries of the rearfoot wedge/heel lift area. The heel cushionprovides shock attenuation and cushioning at heel strike. Leaving theheel cushion unattached reduces the GRF beneath the central heel area totreat certain foot pathologies, and reduces the thickness of the insoleto improve shoe fit.

The shape of the heel cushion may vary provided that the alternativeshapes maintain a position within the heel area do not interfere withthe arch support area.

Preferably, for a men's size medium insole, the heel cushion has alength of approximately 63.3 mm and a width of approximately 38.9 mm.This length and width may vary ±5 mm and still maintain the desiredperformance of the heel cushion and preferably smaller than the rearfootwedge or heel lift. For different sized insoles, the dimensions may beachieved by altering all the dimensions of the heel cushionproportionately.

Preferably the heel cushion is made of a high-density EVA material witha hardness of about 75-80 Asker C. Alternatively, the heel cushion maybe a lower density material with a hardness of about 45-50 Asker C, oralternatively a medium density of 50-75 Asker C. Other materials may beused for heel cushion such as a Polyurethane (PU), Polypropylene (PP),polyethylene (PE), or gel that provides the appropriate hardness andmaterial characteristics to maintain the overall structure andresilience of the heel cushion.

The heel cushion may be secured in the heel cushion area between thebase layer and the rearfoot wedge or heel lift.

While preferred embodiments of the invention have been shown anddescribed, modifications thereof can be made by one skilled in the artwithout departing from the spirit and teachings of the invention. Theembodiments described herein are exemplary only, and are not intended tobe limiting. Many variations and modifications of the inventiondisclosed herein are possible and are within the scope of the invention.

Having described the invention, we claim:
 1. An insole having a top sidefor contacting a user's foot and a bottom side for contacting the insideof a user's shoe, comprising: a. a base having a base top surface, abase bottom surface, a heel end, a toe end, a medial border locatedproximate to an inside medial edge of the base and a lateral borderlocated proximate to an outside lateral edge of the base, said basebottom side having: i. a first metatarsal head pad area extending fromthe medial border to a position under the first metatarsal, ii. aforefoot wedge area that extends from said first metatarsal head padarea to the lateral border along the second through fifth metatarsals,iii. a heel area that extends from about the cuboid of the foot to saidheel end, and, iv. an arch support area that extends longitudinallyunder the arch of the foot on the medial side of the base, b. aninterchangeable arch support positioned under the arch support area,said interchangeable arch support being made of variable strengthmaterial to provide variable strength arch support that extends upwardlyalong the medial border and under the arch of the foot, c. a firstmetatarsal head pad positioned in the first metatarsal head pad area, d.a forefoot wedge pad located in the forefoot wedge area, and e. a heelpad cushion located in the heel area, said heel pad cushion is used witha supplementary pad cushion positioned in the heel area with the heelpad cushion.
 2. The insole of claim 1, wherein said supplementary padcushion is a heel lift pad cushion.
 3. The insole of claim 1, whereinsaid supplementary pad cushion is a rearfoot wedge pad cushion.
 4. Theinsole of claim 1, wherein said arch support is a rigid support.
 5. Theinsole of claim 1, wherein said arch support is a flexible support. 6.The insole of claim 1, wherein said forefoot wedge pad tapers from athicker lateral edge to a thinner medial edge.
 7. The insole of claim 1,wherein said heel lift tapers from a thicker proximal edge to a thinnerdistal edge.
 8. The insole of claim 1, wherein said rearfoot wedgetapers from a thicker medial edge to a thinner lateral edge.
 9. Aninsole having a top side for contacting a user's foot and a bottom sidefor contacting the inside of a user's shoe, comprising: a. a base havinga base top surface, a base bottom surface, a heel end, a toe end, amedial border located proximate to an inside medial edge of the base anda lateral border located proximate to an outside lateral edge of thebase, said base bottom side having: i. a first metatarsal head pad areaextending from the medial border to a position under the firstmetatarsal, ii. a forefoot wedge area that extends from said firstmetatarsal head pad area to the lateral border along the second throughfifth metatarsals, iii. a heel area that extends from about the cuboidof the foot to said heel end, and, iv. an arch support area that extendslongitudinally under the arch of the foot on the medial side of thebase, b. an interchangeable arch support positioned under the archsupport area that possesses variable rigid strength and based one whichof one or more interchangeable arch supports are placed in the archsupport area to provide variable support in the arch area that extendsupwardly along the medial border and under the arch of the foot, and c.a heel pad cushion located in the heel area.
 10. The insole of claim 9,wherein said arch support has a variable strength rigid material toprovide a variable strength arch support.
 11. The insole of claim 10,wherein said arch support is a rigid support.
 12. The insole of claim10, wherein said arch support is a flexible support.
 13. The insole ofclaim 9, further comprising: a first metatarsal head pad positioned inthe first metatarsal head pad area.
 14. The insole of claim 9, furthercomprising: a forefoot wedge pad located in the forefoot wedge area 15.The insole of claim 14, wherein said forefoot wedge pad tapers from athicker lateral edge to a thinner medial edge.
 16. The insole of claim9, wherein said heel pad cushion is used with a heel lift pad cushion,respectively positioned in the heel area with the heel pad cushion. 17.The insole of claim 16, wherein said heel lift tapers from a thickerproximal edge to a thinner distal edge.
 18. The insole of claim 9,wherein said heel pad cushion is used with a rearfoot wedge pad cushion,respectively positioned in the heel area with the heel pad cushion. 19.The insole of claim 18, wherein said rearfoot wedge tapers from athicker medial edge to a thinner lateral edge.
 20. A method of making aninsole having a top side for contacting a user's foot and a bottom sidefor contacting the inside of a user's shoe, comprising the steps of: a.providing a base having a base top surface, a base bottom surface, aheel end, a toe end, a medial border located proximate to an insidemedial edge of the base and a lateral border located proximate to anoutside lateral edge of the base, said base bottom side having: i. afirst metatarsal head pad area extending from the medial border to aposition under the first metatarsal, ii. a forefoot wedge area thatextends from said first metatarsal head pad area to the lateral borderalong the second through fifth metatarsals, iii. a heel area thatextends from about the cuboid of the foot to said heel end, and, iv. anarch support area that extends longitudinally under the arch of the footon the medial side of the base, b. attaching a variable strength archsupport to the base under the arch support area, said arch support beinginterchangeable with one or more variable strength arch supportmaterials to provide variable strength arch support that extendsupwardly along the medial border and under the arch of the foot, c.attaching a first metatarsal head pad to the base positioned in thefirst metatarsal head pad area, d. attaching a forefoot wedge pad to thebase located in the forefoot wedge area, e. attaching a heel pad cushionto the base located in the heel area, and f. attaching a supplementarypad cushion to the base and heel pad cushion, respectively positioned inthe heel area with the heel pad cushion.
 21. The method of claim 20,wherein said supplementary pad cushion is a heel lift pad cushion. 22.The method of claim 20, wherein said supplementary pad cushion is arearfoot wedge pad cushion.
 23. The method of claim 20, wherein saidarch support is a rigid support.
 24. The method of claim 20, whereinsaid arch support is a flexible support.
 25. The method of claim 20,wherein said forefoot wedge pad tapers from a thicker lateral edge to athinner medial edge.
 26. The method of claim 20, wherein said heel lifttapers from a thicker proximal edge to a thinner distal edge.
 27. Themethod of claim 20, wherein said rearfoot wedge tapers from a thickermedial edge to a thinner lateral edge.